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Sample records for bioequivalence recommendations active

  1. 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... Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of...

  2. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability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... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendation... design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)...

  3. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Science.gov (United States)

    2010-06-11

    ... comment on those recommendations. In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the... Bioequivalence Recommendations for Specific Products; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Bioequivalence Recommendations for Specific Products.'' This...

  4. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...

  5. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Science.gov (United States)

    2012-03-28

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide...

  6. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The...

  7. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Science.gov (United States)

    2012-09-20

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.''...

  8. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Science.gov (United States)

    2013-09-10

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for...

  9. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Science.gov (United States)

    2012-02-13

    .... Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram...

  10. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Science.gov (United States)

    2013-03-29

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.''...

  11. 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... for Nitroglycerin Metered Spray/Sublingual Products and Metered Aerosol/ Sublingual Products... Recommendations for Nitroglycerin,'' one for nitroglycerin metered spray/sublingual products and one...

  12. 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

  13. 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...

  14. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Science.gov (United States)

    2013-12-05

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and... for Paliperidone Palmitate.'' The guidance provides specific recommendations on the design...

  15. 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.

  16. 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

  17. 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

  18. 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...

  19. 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...

  20. 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.

  1. Bioavailability & Bioequivalence Studies ? Pharmaceutical Importance

    OpenAIRE

    Pratibha Muntha

    2015-01-01

    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 the...

  2. 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

  3. 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

  4. 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...

  5. Decision analysis and bioequivalence trials

    OpenAIRE

    Lindley, Dennis V.

    1998-01-01

    It is argued that the determination of bioequivalence involves a decision, and is not purely a problem of inference. A coherent method of decision-making is examined in detail for a simple trial of bioequivalence. The result is shown to differ seriously from the inferential method, using significance tests, ordinarily used. The reason for the difference is explored. It is shown how the decision-analytic method can be used in more complicated and realistic trials and the case...

  6. On equivalence and bioequivalence testing

    OpenAIRE

    Ocaña, Jordi; Sánchez, M. Pilar; Sánchez, Álex; Carrasco, Josep Lluís

    2008-01-01

    Equivalence testing is the natural approach to many statistical problems. First, its main application, bioequivalence testing, is reviewed. The basic concepts of bioequivalence testing (2×2 crossover designs, TOST, interval inclusion principle, etc.) and its problems (TOST biased character, the carryover problem, etc.) are considered. Next, equivalence testing is discussed more generally. Some applications and methods are reviewed and the relation of equivalence testing and distance-based...

  7. 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... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

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

    DEFF Research Database (Denmark)

    Bendix, Jane; Hegaard, Hanne Kristine; Bergholt, Thomas; Langhoff-Roos, Jens

    2015-01-01

    Abstract Aims: To describe specific recommendations of activity restriction, place of care, expected beneficial and adverse effects, and recommended antithrombotic prophylaxis in nine clinical scenarios. Methods: A national survey. All members of the Danish Society of Obstetrics and Gynaecology a...

  9. 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

  10. Nordic Nutrition Recommendations2004 - integrating nutrition and physical activity

    OpenAIRE

    Becker, Wulf; Lyhne, Niels; Agnes N. Pedersen; Aro, Antti; Fogelholm, Mikael; Phórsdottir, Phórsdottir; Alexander, Jan; Anderssen, Sigmund A; Meltzer, Helle M.; Jan I. Pedersen

    2008-01-01

    The 4th edition of the Nordic Nutrition Recommendations, NNR 2004, gives the proportions between energy yielding nutrients, recommended daily intakes (RI) of certain vitamins and minerals, and reference values for energy intakes in different age and sex groups. Recommendations are also given for dietary fibre, salt and alcohol. Recommendations on daily physical activity are now included and interaction with physical activity has been taken into account for the individual nutrient recommendati...

  11. 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

  12. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-06-20

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised, that... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  13. 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... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  14. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-02-22

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... comment. Recommendations were last announced in the Federal Register of January 25, 2012 (77 FR 3777... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  15. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-06-14

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... comment. Recommendations were last announced in the Federal Register of March 28, 2012 (77 FR 18827). This... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  16. 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... Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration,...

  17. "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.

  18. [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

  19. 21 CFR 320.63 - Retention of bioequivalence samples.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Retention of bioequivalence samples. 320.63... (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.63 Retention of bioequivalence...

  20. 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...

  1. 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...

  2. A note on an individual bioequivalence setting

    OpenAIRE

    Surulescu, Christina; Surulescu, N.

    2005-01-01

    We give a new simpler proof along with a generalization for the inequality of Yao and Iyer \\cite{yao} arising in bioequivalence studies and by using a nonparametric approach we also discuss an extension of the individual bioequivalence setting to the case where the data are not necessarily normally distributed.

  3. 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

  4. "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.

  5. 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

  6. 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...

  7. Consistency of the Bootstrap Procedure in Individual Bioequivalence

    OpenAIRE

    Shao, J.; Kübler, J.; Pigeot, Iris

    1999-01-01

    Recently, new concepts have been proposed for assessing bioequivalence of two drug formulations, namely the so-called population and individual bioequivalence. Using moment-based and probability-based measures for evaluating the proposed bioequivalence concepts, criteria have been formulated to decide whether two formulations should be regarded as bioequivalent or not. This decision has of course to be based on an adequate statistical method where the Food and Drug Administration (FDA) guidan...

  8. 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...

  9. 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

  10. 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.

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

    OpenAIRE

    Saber Pahlavan; Morteza Hajizadeh; Adel Azadkhah; Ali Ansarifard

    2013-01-01

    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 si...

  12. 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.

  13. 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.

  14. 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.

  15. Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets

    OpenAIRE

    Tatiane Maria de Lima Souza Brioschi; Simone Grigoleto Schramm; Eunice Kazue Kano; Eunice Emiko Mori Koono; Ting Hui Ching; Cristina Helena dos Reis Serra; Valentina Porta

    2013-01-01

    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. Pharmaco...

  16. An unbiased test for the bioequivalence problem

    OpenAIRE

    Brown, Lawrence D.; Hwang, J. T. Gene; Munk, Axel

    1997-01-01

    It is shown that the standard two one-sided tests procedure for bioequivalence is a biased test. Better tests exist. In this paper, an unbiased $\\alpha$-level test and other tests which are uniformly more powerful than the two one-sided tests procedure are constructed. Its power can be noticeably larger than that of the $\\alpha$-level two one-sided tests procedure.

  17. 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

  18. 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.

  19. 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

  20. Pharmacogenetic Selection of Volunteers Increases Stringency of Bioequivalence Studies; The Case of Clopidogrel

    OpenAIRE

    Garcés-Eisele, J.; Ruiz-Argüelles, A.; Larisa Estrada-Marín; Virginia Reyes-Núñez; Vázquez-Pérez, R.; Olga Guzmán-García; Coutiño-Medina, R.; Leticia Acosta-Sandria; Beatriz Cedillo-Carvallo

    2014-01-01

    Clinical response to clopidogrel varies widely due to under-dosing, drug interactions and intrinsic interindividual differences resulting from genetic polymorphisms. Cytochrome P450-2C19 is the principal enzyme involved in the activation of the prodrug and loss-of-function alleles have been described. Upon expiration of the pharmaceutical patent of clopidogrel, generic manufacturers have started to subject interchangeable formulations to bioequivalence studies. The purpose of the current inve...

  1. Agritourism as an economic activity – dilemmas and recommendations

    OpenAIRE

    Agnieszka Brelik

    2013-01-01

    Agritourism as an economic, social, and cultural phenomenon is a part of triggering regional development. It should consider whether regulations concerning the functioning of the agritourism as a business are properly formulated and correspond to the needs of both tourists and the owners of tourism farm. The purpose of this article is an attempt to assess the legislative business on the farm tourism and an indication of the proposals and recommendations of a farm as a business. The article us...

  2. Agritourism as an economic activity – dilemmas and recommendations

    Directory of Open Access Journals (Sweden)

    Agnieszka Brelik

    2013-06-01

    Full Text Available Agritourism as an economic, social, and cultural phenomenon is a part of triggering regional development. It should consider whether regulations concerning the functioning of the agritourism as a business are properly formulated and correspond to the needs of both tourists and the owners of tourism farm. The purpose of this article is an attempt to assess the legislative business on the farm tourism and an indication of the proposals and recommendations of a farm as a business. The article uses the available professional literature, as well as normative and legal acts of the civil code. The article has a theoretical review nature.

  3. 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.

  4. 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.

  5. 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...

  6. Futility Rules in Bioequivalence Trials with Sequential Designs

    OpenAIRE

    Fuglsang, Anders

    2013-01-01

    Health Canada, the US Food and Drug Administration, as well as the European Medicines Agency consider sequential designs acceptable for bioequivalence studies as long as the type I error is controlled at 5%. The EU guideline explicitly asks for specification of stopping rules, so the goal of this work is to investigate how stopping rules may affect type I errors and power for recently published sequential bioequivalence trial designs. Using extensive trial simulations, five different futility...

  7. A Survey of the Likelihood Approach to Bioequivalence Trials

    OpenAIRE

    Choi, Leena; Caffo, Brian; Rohde, Charles

    2008-01-01

    Bioequivalence trials are abbreviated clinical trials whereby a generic drug or new formulation is evaluated to determine if it is “equivalent” to a corresponding previously approved brand-name drug or formulation. In this manuscript, we survey the process of testing bioequivalence and advocate the likelihood paradigm for representing the resulting data as evidence. We emphasize the unique conflicts between hypothesis testing and confidence intervals in this area - which we believe are indica...

  8. Statistical aspects of bioequivalence assessment in the pharmaceutical industry.

    OpenAIRE

    Patterson, S. D.

    2003-01-01

    Since the early 1990's, average bioequivalence studies have served as the international standard for demonstrating that two formulations of drug product will provide the same therapeutic benefit and safety profile when used in the marketplace. Population (PBE) and Individual (IBE) bioequivalence have been the subject of intense international debate since methods for their assessment were proposed in the late 1980's. Guidance has been proposed by the Food and Drug Administration...

  9. Bioequivalence trials, intersection-union tests and equivalence confidence sets

    OpenAIRE

    Berger, Roger L.; Jason C Hsu

    1996-01-01

    The bioequivalence problem is of practical importance because the approval of most generic drugs in the United States and the European Community (EC) requires the establishment of bioequivalence between the brand-name drug and the proposed generic version. The problem is theoretically interesting because it has been recognized as one for which the desired inference, instead of the usual significant difference, is practical equivalence. The concept of intersection-union tests will be shown to ...

  10. 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

  11. 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....

  12. Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability

    OpenAIRE

    Jianghao Li; Shein-Chung Chow

    2015-01-01

    For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study. A test product is said to be average bioequivalent to a reference (innovative) product if the 90% confidence interval of the ratio of means (after log-transformation) is totally within (80%, 125%). This approach is considered a one-parameter approach, which does not account for possible heterogeneity of...

  13. Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada

    OpenAIRE

    Galgatte, Upendra C.; Jamdade, Vijay R.; Aute, Pravin P.; Chaudhari, Pravin D.

    2013-01-01

    The present study was aimed to study the requirements of bioequivalence for the registration of pharmaceutical products in the USA, Europe and Canada. Before going into bioequivalence studies it is essential for the pharmaceutical industry to study the guidelines of bioequivalence for the respective country where the industry wants to market its products and thus enter into generic market. This study reviews the requirements of bioequivalence with study parameters such as study design, fastin...

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

    DEFF Research Database (Denmark)

    Ortiz, P. Garcia; Hansen, Steen Honore'; Shah, V. 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....

  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. 21 CFR 320.22 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

    Science.gov (United States)

    2010-04-01

    ... bioavailability or bioequivalence. 320.22 Section 320.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products §...

  17. 21 CFR 320.21 - Requirements for submission of bioavailability and bioequivalence data.

    Science.gov (United States)

    2010-04-01

    ... bioequivalence data. 320.21 Section 320.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.21 Requirements...

  18. 21 CFR 320.24 - Types of evidence to measure bioavailability or establish bioequivalence.

    Science.gov (United States)

    2010-04-01

    ... establish bioequivalence. 320.24 Section 320.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.24 Types of...

  19. 21 CFR 320.32 - Procedures for establishing or amending a bioequivalence requirement.

    Science.gov (United States)

    2010-04-01

    ... bioequivalence requirement. 320.32 Section 320.32 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.32 Procedures...

  20. 21 CFR 320.36 - Requirements for maintenance of records of bioequivalence testing.

    Science.gov (United States)

    2010-04-01

    ... bioequivalence testing. 320.36 Section 320.36 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.36 Requirements...

  1. 21 CFR 320.23 - Basis for measuring in vivo bioavailability or demonstrating bioequivalence.

    Science.gov (United States)

    2010-04-01

    ... demonstrating bioequivalence. 320.23 Section 320.23 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.23 Basis...

  2. 21 CFR 320.33 - Criteria and evidence to assess actual or potential bioequivalence problems.

    Science.gov (United States)

    2010-04-01

    ... potential bioequivalence problems. 320.33 Section 320.33 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products §...

  3. 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.

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

    Directory of Open Access Journals (Sweden)

    Z. Bahramian

    2015-12-01

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

  5. Seizure-Precipitating Factors in Relation to medical Recommendations: Especially Those Limiting Physical Activity.

    Science.gov (United States)

    Stanuszek, Agnieszka; Wnękowicz, Emilia; Kuźniar, Ewelina; Krakowska, Karolina; Gergont, Aleksandra; Kaciński, Marek

    2015-10-01

    Identification of factors precipitating epileptic seizures should always have practical implications and should always result in special recommendations given to patients. The purpose of our study is to analyze the relation between seizure-triggering factors and restrictive recommendations involving limitation of physical activity in particular. The research group consisted of 407 children hospitalized due to seizures. Their precipitants were identified in 27.5% of the patients. The most common included infection/fever, stress, and flashing lights. Although sport was documented as a precipitant in only 3.4% of all children, 8.1% of the investigated group were recommended to limit physical activity. As some episodes of epileptic seizures are reported to be provoked by sport, multiple restrictions are imposed on children. In the light of the worldwide academic literature and the present study, the recommendation of limiting sports activity is no longer supported. PMID:25808459

  6. 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 ...

  7. 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 ...

  8. Bioequivalence evaluation of two brands of rivastigmine of different salt forms, an acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, in healthy Beagle dogs.

    Science.gov (United States)

    Shen, Cidan; Yang, Bei; Zhou, Tao; Duan, Gengli; Yu, Yingjia

    2011-08-01

    The bioequivalence of two brands of rivastigmine capsules, of different salt forms, was demonstrated in six healthy beagle dogs after a single oral dose in a randomized cross-over study. Reference (Rivastigmine hydrochloride, Sunve, CN) and test (Rivastigmine tartrate, Novartis, CH) products were administered to fasting beagles on two treatment days separated by a two-day washout period; blood samples were collected at specified time intervals, and the plasma was separated and analyzed for rivastigmine using a validated GC-MS method. The pharmacokinetic parameters AUC(0-t), AUC(0-infinity), C(max), T(max) and t1/2 were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by the State Food and Drug Administration (SFDA) of China. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable ranges for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetic profiles and that Sanwei's Rivastigmine hydrochloride was bioequivalent to Rivastigmine tartrate of Novartis, CH. PMID:21901981

  9. 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.

  10. 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.

  11. 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...

  12. 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

  13. 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

  14. 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 ...

  15. 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

  16. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability.

    Science.gov (United States)

    Bialer, Meir; Midha, Kamal K

    2010-06-01

    Most antiepileptic drugs (AEDs) are currently available as generic products, yet neurologists and patients are reluctant to switch to generics. Generic AEDs are regarded as bioequivalent to brand AEDs after meeting the average bioequivalence criteria; consequently, they are considered to be interchangeable with their respective brands without loss of efficacy and safety. According to the U.S. Food and Drug Administration (FDA) the present bioequivalence requirements are already so rigorous and constrained that there is little possibility that generics that meet regulatory bioequivalence criteria could lead to therapeutic problems. So is there a scientific rationale for the concerns about switching patients with epilepsy to bioequivalent generics? Herein we discuss the assessment of bioequivalence and propose a scaled-average bioequivalence approach where scaling of bioequivalence is carried out based on brand lot-to-lot variance as an alternative to the conventional bioequivalence test as a means to determine whether switching patients to generic formulations, or vice versa, is a safe and effective therapeutic option. Meeting the proposed scaled-average bioequivalence requirements will ensure that when an individual patient is switched, he or she has fluctuations in plasma levels similar to those from lot-to-lot of the brand reference levels and thus should make these generic products safely switchable without change in efficacy and safety outcomes. PMID:20384761

  17. 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-

  18. What One Activity Would You Recommend to Teachers Who are Nervous about Teaching Poetry?

    Science.gov (United States)

    Johnson, Walter H.; Sottile, Joseph; Witting, Charlotte R.

    2006-01-01

    In this brief column, three teachers submit recommendations on strategies and activities for teaching poetry. Walter H. Johnson suggests that using sonnets as an introduction to poetry can be a rewarding way to combine poetry terminology, a bit of literary history, and the search for meaning in poems. Joseph Sottile describes a classroom activity…

  19. Overcoming the Influence of Chronic Pain on Older Patients' Difficulty with Recommended Self-Management Activities

    Science.gov (United States)

    Krein, Sarah L.; Heisler, Michele; Piette, John D.; Butchart, Amy; Kerr, Eve A.

    2007-01-01

    Purpose: Many older patients with common chronic conditions also experience chronic pain. We examined how chronic pain affects patients' difficulty with recommended self-management activities and the potential intervening role of self-efficacy (the level of confidence in one's own ability to perform a specific task). Design and Methods: We…

  20. Using an Active Sensor to Calculate Site-Specific Nitrogen Sidedress Recommendations for Corn in Pennsylvania

    Science.gov (United States)

    Active sensors mounted on typical agricultural equipment could potentially be used to improve N (nitrogen) fertilizer recommendations and minimize nitrate losses to the environment, if N status and Economic Optimum N Rate (EONR) can be accurately determined for corn (Zea mays L). This study examine...

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

    DEFF Research Database (Denmark)

    Grøntved, A.

    2013-01-01

    Physical activity (PA) is considered a cornerstone in weight control and public health guidelines recommend regular participation to prevent gains in adiposity. It may therefore come as a surprise that the cumulative evidence from observational studies to support this is not strong. A weakness of...

  2. 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

  3. Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies

    OpenAIRE

    Torrado, Juan José; Blanco, María; Farré, Magí; Roset, Pere; García-Arieta, Alfredo

    2010-01-01

    Abstract Purpose The aim of the present work was to assess the need for chiral bioanalytical methods in bioequivalence studies. Methods The samples from a bioequivalence study of two ibuprofen 2% oral suspensions that had shown bioequivalence for AUC and Cmax, but not for tmax (medians of 2.0 and 0.75 h) with a non-chiral method were assayed with a chiral method to investigate whether there was an actual d...

  4. Model-based analyses of bioequivalence crossover trials using the stochastic approximation expectation maximisation algorithm.

    OpenAIRE

    Dubois, Anne; Lavielle, Marc; Gsteiger, Sandro; Pigeolet, Etienne; Mentré, France

    2011-01-01

    In this work, we develop a bioequivalence analysis using nonlinear mixed effects models (NLMEM) that mimics the standard noncompartmental analysis (NCA). We estimate NLMEM parameters, including between-subject and within-subject variability and treatment, period and sequence effects. We explain how to perform a Wald test on a secondary parameter, and we propose an extension of the likelihood ratio test for bioequivalence. We compare these NLMEM-based bioequivalence tests with standard NCA-bas...

  5. 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

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

    DEFF Research Database (Denmark)

    Zach, Florian; Gretzel, Ulrike

    2011-01-01

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

  7. 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...... assess bioequivalence. Ninety percent confidence intervals were calculated using the two one-sided test procedure and limits of 80-125% based on log-transformed data were used as acceptance criteria to declare bioequivalence. The intra-subject variability was 10% between probes whereas inter......-subject variability was 68% (n=18). Bioequivalence was confirmed with a power greater than 90%....

  8. 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...

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

    Science.gov (United States)

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

    2013-02-01

    Sports activity after total joint arthroplasty (TJA) has become an increasingly important topic, as many younger patients seeking TJA have higher postoperative expectations with regard to return to athletic activity. Our current knowledge of this area is largely based on retrospective clinical studies and surveys of surgeon recommendations. The decision to participate in sports after TJA depends on the patient's general health, prior athletic experience, type of TJA, and desired sporting activity. Ultimately, patients should discuss these factors with their physician in order to make an educated decision regarding sports activity after TJA. This article summarizes the best available evidence to help guide physicians in their conversation with patients regarding safe and appropriate sports activity after TJA. PMID:23445855

  10. 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.

  11. Bioequivalence Study of Donepezil Hydrochloride Tablets in Healthy Male Volunteers

    OpenAIRE

    Supanimit Teekachunhatean; Sukit Roongapinun; Nutthiya Hanprasertpong; Siriluk Aunmuang; Noppamas Rojanasthien

    2012-01-01

    The objective of this study was to investigate the bioequivalence of two formulations of 5 mg donepezil HCL tablets: Tonizep as the test and Aricept as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 3-week washout period in 20 healthy Thai Male volunteers. After drug administration, serial blood samples were collected over a period of 216 hours. Plasma donepezil concentrations were measured by high performance liqui...

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

    OpenAIRE

    Sclar DA

    2013-01-01

    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 ...

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

    OpenAIRE

    Sclar, David

    2013-01-01

    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...

  14. 21 CFR 320.26 - Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

    Science.gov (United States)

    2010-04-01

    ... bioavailability or bioequivalence study. 320.26 Section 320.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products §...

  15. 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.

  16. 21 CFR 320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Inquiries regarding bioavailability and... FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS Procedures for Determining the Bioavailability or Bioequivalence of Drug Products § 320.30 Inquiries regarding bioavailability and...

  17. 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

  18. The bootstrap and Bayesian bootstrap method in assessing bioequivalence

    International Nuclear Information System (INIS)

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

  19. [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

  20. 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

  1. 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

  2. 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.

  3. Bioavailability and Bioequivalence in Drug Development

    OpenAIRE

    Chow, Shein-Chung

    2014-01-01

    Bioavailability is referred to as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes available at the site of drug action. The relative bioavailability in terms of the rate and extent of drug absorption is considered predictive of clinical outcomes. In 1984, the United States Food and Drug Administration (FDA) was authorized to approve generic drug products under the Drug Price Competition and Patent Term Restoration Act base...

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

    OpenAIRE

    Z. Bahramian; Ali Abbaspour, R.

    2015-01-01

    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 prefere...

  5. 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

  6. Use of pharmacogenetics in bioequivalence studies to reduce sample size: an example with mirtazapine and CYP2D6.

    Science.gov (United States)

    González-Vacarezza, N; Abad-Santos, F; Carcas-Sansuan, A; Dorado, P; Peñas-Lledó, E; Estévez-Carrizo, F; Llerena, A

    2013-10-01

    In bioequivalence studies, intra-individual variability (CV(w)) is critical in determining sample size. In particular, highly variable drugs may require enrollment of a greater number of subjects. We hypothesize that a strategy to reduce pharmacokinetic CV(w), and hence sample size and costs, would be to include subjects with decreased metabolic enzyme capacity for the drug under study. Therefore, two mirtazapine studies, two-way, two-period crossover design (n=68) were re-analysed to calculate the total CV(w) and the CV(w)s in three different CYP2D6 genotype groups (0, 1 and ≥ 2 active genes). The results showed that a 29.2 or 15.3% sample size reduction would have been possible if the recruitment had been of individuals carrying just 0 or 0 plus 1 CYP2D6 active genes, due to the lower CV(w). This suggests that there may be a role for pharmacogenetics in the design of bioequivalence studies to reduce sample size and costs, thus introducing a new paradigm for the biopharmaceutical evaluation of drug products. PMID:22733239

  7. Pro-active Multi-Dimensional Recommender System using Multi-Agents

    Directory of Open Access Journals (Sweden)

    Hend Al Tair

    2012-07-01

    Full Text Available Recommender systems currently used in many applications, including tourism, tend to simply be reactive to user request. The recommender system proposed in this paper uses multi-agents and multi-dimensional contextual information to achieve proactive behavior. User profile and behavior get implicitly incorporated and subsequently updated in the system. The recommender system has been developed and applied to the tourism domain. It was tested and evaluated by relatively large set of real users The evaluation conducted shows that most of the users are satisfied with the functionality of the system and its ability to produce the recommendation adaptively and proactively taking into considerations different factors.

  8. 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

  9. 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

  10. Bioequivalence of Sandoz methylphenidate osmotic-controlled release tablet with Concerta® (Janssen-Cilag)

    OpenAIRE

    Schapperer, Elisabeth; Daumann, Heike; Lamouche, Stéphane; Thyroff-Friesinger, Ursula; Viel, François; Weitschies, Werner

    2015-01-01

    The aim was to assess the bioequivalence of Sandoz methylphenidate osmotic-controlled release (OCR) tablets (Sandoz [Methylphenidate[ MPH OCR) with Concerta®, a methylphenidate formulation indicated for the treatment of attention deficit/hyperactivity disorder (ADHD). Four open-label, randomized, single-dose, two-way crossover bioequivalence studies were conducted in healthy subjects: three fasting studies with 54-, 36- and 18-mg doses of methylphenidate, and one fed study with the 54-mg dose...

  11. Formulation and Bioequivalence of Two Valsartan Tablets After a Single Oral Administration

    OpenAIRE

    Zaid, Abdel Naser; Cortesi, Rita; Qaddomi, Aiman; Khammash, Saed

    2010-01-01

    The aim of this study is to assess the quality of Valzan® tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan® tablet (160 mg, valsartan reference formulation). Valzan® tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan® tablets a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy male volunteers. The selected volunteers were divide...

  12. Metabolite Parameters as an Appropriate Alternative Approach for Assessment of Bioequivalence of Two Verapamil Formulations

    OpenAIRE

    Haeri, Azadeh; Javadian, Bahareh; Saadati, Roonak; Dadashzadeh, Simin

    2014-01-01

    A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibility of proving bioequivalence of verapamil oral dosing form by means of norverapamil pharmacokinetic ...

  13. Timing of tissue plasminogen activator for acute ischemic stroke: outcomes-based recommendations for practice.

    Science.gov (United States)

    Hanselman, Carol J

    2014-12-01

    Acute ischemic stroke (AIS) is a major cause of death and disability in the United States. Tissue plasminogen activator (t-PA) is an intravenously administered therapy that can prevent death and disability for patients presenting within early onset of AIS. There has been a debate around the exact time parameters for administration, because very few patients present to the hospital within the initial 0- to 3-hour window of time. Not all of the current national guidelines for timing of AIS in the United States are in agreement with regards to this issue. To the nurse caring for patients with neurologic illnesses, this topic is of utmost importance. Nurse are not only involved in determining the time of stroke symptom onset, but nurses also hold responsibility for a working knowledge of the latest eligibility and exclusion criteria for t-PA administration. This article examines the central body of research related to the timing of t-PA and makes recommendations for eligible candidates based on this literature. PMID:25365047

  14. 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...

  15. Bioequivalence and Bioavailability Clinical Trials: A Status Report from the National Institutes of Health ClinicalTrials.gov Registry

    OpenAIRE

    Stockmann, Chris; Spigarelli, Michael G.; Ampofo, Krow; Sherwin, Catherine MT

    2013-01-01

    Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a national clinical trials registry. All bioequivalence and bioavailability studies registered in the United...

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

    Science.gov (United States)

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

    2016-05-01

    A taskforce, under the auspices of The International Association of Gerontology and Geriatrics-Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section, composed of experts from the fields of exercise science and geriatrics, met in Toulouse, in December 2015, with the aim of establishing recommendations of physical activity and exercise for older adults living in long-term care facilities (LTCFs). Due to the high heterogeneity in terms of functional ability and cognitive function that characterizes older adults living in LTCFs, taskforce members established 2 sets of recommendations: recommendations for reducing sedentary behaviors for all LTCF residents and recommendations for defining specific, evidence-based guidelines for exercise training for subgroups of LTCF residents. To promote a successful implementation of recommendations, taskforce experts highlighted the importance of promoting residents' motivation and pleasure, the key factors that can be increased when taking into account residents' desires, preferences, beliefs, and attitudes toward physical activity and exercise. The importance of organizational factors related to LTCFs and health care systems were recognized by the experts. In conclusion, this taskforce report proposes standards for the elaboration of strategies to increase physical activity as well as to prescribe exercise programs for older adults living in LTCFs. This report should be used as a guide for professionals working in LTCF settings. PMID:27012368

  17. Recommendations for Technology Development and Validation Activities in Support of the Origins Program

    Science.gov (United States)

    Capps, Richard W. (Editor)

    1996-01-01

    space optics, OSAT is moving to improve the focus of its sensor, spacecraft, and interferometer/telescope technology programs on the specific additional needs of the OSS Origins Program. To better define Origins mission technology and facilitate its development, OSAT and OSS called for a series of workshops with broad participation from industry, academia and the national laboratory community to address these issues. Responsibility for workshop implementation was assigned jointly to the two NASA field centers with primary Origins mission responsibility, the Goddard Space Flight Center and the Jet Propulsion Laboratory. The Origins Technology Workshop, held at Dana Point, California between June 4 and 6, 1996 was the first in the series of comprehensive workshops aimed at addressing the broad technological needs of the Origins Program. It was attended by 64 individuals selected to provide technical expertise relevant to the technology challenges of the Origins missions. This report summarizes the results of that meeting. A higher level executive summary was considered inappropriate because of the potential loss of important context for the recommendations. Subsequent to the Origins Technology Workshop and prior to publication of this report, NASA Headquarters reorganized the activities of the Of fice of Space Access and Technology. It appears likely that responsibility for the technology programs recommended in this document will move to the Office of Space Science.

  18. Underserved minority children are not meeting the US public health recommendation for moderate-vigorous physical activity

    Science.gov (United States)

    In the US childhood obesity is more prevalent among underserved minority children. It is recommended that children should spend a minimum of 60 min/d in moderate-vigorous physical activity (MVPA) in order to maintain a healthy body weight. We measured the amount of MVPA based on a minimum of 5 conse...

  19. 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

  20. 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.

  1. 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 ...

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

    International Nuclear Information System (INIS)

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

  3. 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...

  4. 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...

  5. 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

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

    International Nuclear Information System (INIS)

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

  7. 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…

  8. 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…

  9. High-frequency brain activity and muscle artifacts in MEG/EEG: a review and recommendations

    OpenAIRE

    Suresh Muthukumaraswamy

    2013-01-01

    In recent years high-frequency brain activity in the gamma-frequency band (30–80 Hz) and above has become the focus of a growing body of work in MEG/EEG research. Unfortunately, high-frequency neural activity overlaps entirely with the spectral bandwidth of muscle activity (~20–300 Hz). It is becoming appreciated that artifacts of muscle activity may contaminate a number of non-invasive reports of high-frequency activity. In this review, the spectral, spatial, and temporal characteristics of ...

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

    Science.gov (United States)

    Pitner, Nancy J.; Russell, James S.

    1986-01-01

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

  11. 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…

  12. Using an active sensor to make in-season nitrogen recommendations for corn

    Science.gov (United States)

    An active crop canopy reflectance sensor could 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 application. Our objective was to evaluate the success of using an active sensor ...

  13. 4 out of 5 Students Surveyed Would Recommend this Activity (Comparing Chewing Gum Flavor Durations)

    Science.gov (United States)

    Richardson, Mary; Rogness, Neal; Gajewski, Byron

    2005-01-01

    This paper describes an interactive activity developed for illustrating hypothesis tests on the mean for paired or matched samples. The activity is extended to illustrate assessing normality, the Wilcoxon signed rank test, Kaplan-Meier survival functions, two-way analysis of variance, and the randomized block design. (Contains 6 tables and 13…

  14. International recommendations

    International Nuclear Information System (INIS)

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

  15. 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

  16. STATE OF THE ART OF A MULTI-AGENT BASED RECOMMENDER SYSTEM FOR ACTIVE SOFTWARE ENGINEERING ONTOLOGY

    Directory of Open Access Journals (Sweden)

    Udsanee Pakdeetrakulwong

    2014-03-01

    Full Text Available Software engineering ontology was first developed to provide efficient collaboration and coordination among distributed teams working on related software development projects across the sites. It helped to clarify the software engineering concepts and project information as well as enable knowledge sharing. However, a major challenge of the software engineering ontology users is that they need the competence to access and translate what they are looking for into the concepts and relations described in the ontology; otherwise, they may not be able to obtain required information. In this paper, we propose a conceptual framework of a multi-agent based recommender system to provide active support to access and utilize knowledge and project information in the software engineering ontology. Multi-agent system and semantic-based recommendation approach will be integrated to create collaborative working environment to access and manipulate data from the ontology and perform reasoning as well as generate expert recommendation facilities for dispersed software teams across the sites.

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

    Science.gov (United States)

    Pitner, Nancy J.; Russell, James S.

    1986-01-01

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

  18. 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.

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

    International Nuclear Information System (INIS)

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

  20. 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

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

    DEFF Research Database (Denmark)

    Lynggaard, Per

    2013-01-01

    information provided by sensors. However, an alternative concept using a distributed framework is presented in this paper. It offers the possibility of combining simple low level activity classifiers with a more sophisticated one. The high level classifier has been modeled in Java and tested on a publicly...... 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%....

  2. Acculturation, sociodemographic and lifestyle factors associated with compliance with physical activity recommendations in the Mexican-American Mano A Mano cohort

    OpenAIRE

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

    2015-01-01

    Objectives Being physically active is important for health, and few Mexican-Americans meet national US physical activity recommendations. The aim of this study was to investigate sociodemographic, acculturation and lifestyle factors that were associated with meeting physical activity recommendations in this group. Design and setting A cross-sectional analysis of a large population-based cohort study in southern Texas, USA. Participants Between 2001 and 2011, 21 551 adult members of the Mexica...

  3. 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...

  4. 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…

  5. 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...

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

    DEFF Research Database (Denmark)

    Mattsson, Jan; Söderlund, Magnus

    2015-01-01

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

  7. Steps Forward: Review and Recommendations for Research on Walkability, Physical Activity and Cardiovascular Health

    OpenAIRE

    Lovasi, Gina S.; Stephanie Grady; Andrew Rundle

    2011-01-01

    Built environments that support walking and other physical activities have the potential to reduce cardiovascular disease (CVD). Walkable neighborhoods—characterized by density, land use diversity, and well-connected transportation networks—have been linked to more walking, less obesity, and lower coronary heart disease risk. Yet ongoing research on pedestrian-friendly built environments has the potential to address important gaps. While much of the literature has focused on urban form and pl...

  8. 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

  9. 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

    evaluation variables such as customer satisfaction, perceived service quality, and perceived value. Several studies have also examined the association between explicitly rewarded WOM – in terms of referral reward programs, or “recommend-a-friend-programs” – and the customer’s WOM activity. Indeed...... in the private banking sector, and our main result was that a straight-forward request to customers to provide WOM was positively associated with both WOM behavior (in terms of the number of persons talked to) and WOM intentions. Thus, a mere request for WOM seems to make WOM activity more likely to happen....... In addition, we found that receiving WOM requests was not negatively associated with overall evaluations, such as customer satisfaction, which indicates that the potential for negative effects of making the request seems to be low....

  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. 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

  12. 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

  13. 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…

  14. 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.

  15. Antimicrobial activity of cefmetazole (CS-1170) and recommendations for susceptibility testing by disk diffusion, dilution, and anaerobic methods.

    Science.gov (United States)

    Jones, R N; Barry, A L; Fuchs, P C; Thornsberry, C

    1986-12-01

    Cefmetazole, formerly CS-1170, was found to have antimicrobial activity slightly superior to that of cefoxitin but a clinically usable antimicrobial spectrum that should be considered identical to that of cefoxitin. Disk diffusion and dilution test methods with cefmetazole correlated highly (r, greater than or equal to 0.95) with cefoxitin results. The recommended 30-micrograms cefmetazole disk interpretive breakpoints for susceptibility and resistance were greater than or equal to 18 mm (MIC, less than or equal to 8.0 micrograms/ml) and less than or equal to 14 mm (MIC, greater than or equal to 32 micrograms/ml), respectively. Cefmetazole and cefoxitin should be considered to be in the same antimicrobial spectrum class, requiring separate testing for other cephalosporins such as cephalothin, cefamandole, cefuroxime, and cefotetan. Recommended interpretive criteria performed well for fastidious organisms (Haemophilus influenzae, Neisseria meningitidis, and Branhamella catarrhalis) and for broth microdilution tests with anaerobes. Cefmetazole and cefoxitin broth disk elution tests for anaerobic bacteria produced higher rates of false susceptibility results. PMID:3097064

  16. 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.

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

    Science.gov (United States)

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

    2012-10-01

    Skeletal muscle is the major deposit of protein molecules. As for any cell or tissue, total muscle protein reflects a dynamic turnover between net protein synthesis and degradation. Noninvasive and invasive techniques have been applied to determine amino acid catabolism and muscle protein building at rest, during exercise and during the recovery period after a single experiment or training sessions. Stable isotopic tracers ((13)C-lysine, (15)N-glycine, 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. PMID:22666780

  18. 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.

  19. 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

  20. 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

  1. Complete dataset for 2-treatment, 2-sequence, 2-period efavirenz bioequivalence study conducted with nightly dosing.

    Science.gov (United States)

    Ibarra, Manuel; Magallanes, Laura; Lorier, Marianela; Vázquez, Marta; Fagiolino, Pietro

    2016-06-01

    The efavirenz pharmacokinetic raw data presented in this article was obtained in an average bioequivalence study between a local brand and Stocrin (Merck Sharp & Dohme, purchased from Australia, batch H009175, expiration date November 2013). Dose was administered at night (9:00 p.m.) two hours after food intake. Fourteen healthy subjects, 8 women and 6 men, completed the study. For each subject, 15 data points until 96 h post-administration are included. Subject demographic characteristics and sequences of administration are provided along with individual pharmacokinetic profiles of efavirenz obtained for both formulations after a single oral dose of 600 mg. This data provides information in support of the research article "Sex-by-formulation interaction assessed through a bioequivalence study of efavirenz tablets" [1]. PMID:27054190

  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. 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...

  4. 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)

  5. Bioequivalence of the 4-mg Oral Granules and Chewable Tablet Formulations of Montelukast

    OpenAIRE

    Knorr, Barbara; Hartford, Alan; LI, XIUJIANG; Yang, Amy Yifan; Noonan, Gertrude; Migoya, Elizabeth

    2010-01-01

    Purpose The primary objective of the studies was to demonstrate bioequivalence between the oral granules formulation and chewable tablet of montelukast in the fasted state. Effect of food on the pharmacokinetics of the oral granules was also evaluated. Methods The Formulation Biocomparison Study (Study 1) and the Final Market Image Study (Study 2) each used an open-label, randomized, 3-period crossover design where healthy adult subjects (N = 24 and 30, respectively) received montelukast as a...

  6. Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy

    OpenAIRE

    Amidon, KS; Langguth, P; Lennernäs, H; Yu, L; Amidon, GL

    2011-01-01

    The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as th...

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

    OpenAIRE

    Tjandrawinata RR; Setiawati E; Yunaidi DA; Santoso ID; Setiawati A; Susanto LW

    2012-01-01

    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...

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

    OpenAIRE

    Tjandrawinata RR; Setiawati E; Yunaidi DA; Simanjuntak R; Santoso ID; Susanto LW

    2013-01-01

    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 ra...

  9. Complete dataset for 2-treatment, 2-sequence, 2-period efavirenz bioequivalence study conducted with nightly dosing

    OpenAIRE

    Ibarra, Manuel; Magallanes, Laura; Lorier, Marianela; Vázquez, Marta; Fagiolino, Pietro

    2016-01-01

    The efavirenz pharmacokinetic raw data presented in this article was obtained in an average bioequivalence study between a local brand and Stocrin (Merck Sharp & Dohme, purchased from Australia, batch H009175, expiration date November 2013). Dose was administered at night (9:00 p.m.) two hours after food intake. Fourteen healthy subjects, 8 women and 6 men, completed the study. For each subject, 15 data points until 96 h post-administration are included. Subject demographic characteristics an...

  10. Bioequivalence Study of Pantoprazole Sodium-HPBCD and Conventional Pantoprazole Sodium Enteric-Coated Tablet Formulations

    OpenAIRE

    Kamdi, Sandesh P.; Prashant J. Palkar

    2013-01-01

    The objective of this study was to investigate the bioequivalence of two formulations of 40 mg pantoprazole sodium enteric-coated tablets: Tripepsa as the test and Pantocid as the reference. The two products were administered as a single oral dose according to a randomized two-phase crossover with a 1-month washout period in 25 healthy Indian volunteers. After drug administration, serial blood samples were collected over a period of 30 hours. Plasma pantoprazole concentrations were measured b...

  11. Challenges and Opportunities in Achieving Bioequivalence for Fixed-Dose Combination Products

    OpenAIRE

    Mitra, Amitava; Wu, Yunhui

    2012-01-01

    Fixed-dose combination (FDC) products are becoming a popular treatment option because of increased patient compliance and convenience, improved clinical effectiveness, and reduced cost to the patient, among several other reasons. A commonly applied approach for approval of a FDC product is demonstrating bioequivalence between the FDC and co-administration of individual mono-products, provided that there is adequate safety and efficacy data for co-administration of the individual agents. Howev...

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

    OpenAIRE

    Nuggehally R Srinivas

    2011-01-01

    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 poly...

  13. Market Effects of Generic Entry: The Role of Physicians and of Non-Bioequivalent Competitors

    OpenAIRE

    Gonzalez, Jorge; Sismeiro, Catarina; Dutta, Shantanu; Stern, Philip

    2006-01-01

    Patent expiration represents a turning point for the brand losing patent protection as bioequivalent generic versions of the drug quickly enter the market at reduced prices. In this paper, we study how physician characteristics and their prescribing decisions impact the competition among molecules of a therapeutic class, once generic versions of one of these molecules enter the market. Specifically, we study the evolution of the Selective Serotonine Reuptake Inhibitors (SSRIs) after the intro...

  14. 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...

  15. 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

  16. 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.

  17. 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

  18. 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.

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

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

    The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled average bioequivalence' approach. The present paper corroborates previous work suggesting that none of them adequately controls type I error or consumer's risk, so they result in invalid test procedures in the neighbourhood of a within-subject coefficient of variation osf 30% for the reference (R) formulation. The problem is particularly serious in the US Food and Drug Administration regulation, but it is also appreciable in the European Medicines Agency one. For the partially replicated TRR/RTR/RRT and the replicated TRTR/RTRT crossover designs, we quantify these type I error problems by means of a simulation study, discuss their possible causes and propose straightforward improvements on both regulatory procedures that improve their type I error control while maintaining an adequate power. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26707698

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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

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

    OpenAIRE

    Fang Tang; Rui Zhou; Zeneng Cheng; Guoping Yang; Aiqiao Chen; Zhi Liu; Hongyi Tan; Shuang Yang; Sanwang Li; Lingli Mu; Peng Yu

    2015-01-01

    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 for...

  8. 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 ...

  9. 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.

  10. 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.

  11. 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

  12. 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...

  13. 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

  14. 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.

  15. Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers

    OpenAIRE

    Noppamas Rojanasthien; Thatree Autsavakitipong; Boonyium Kumsorn; Maleeya Manorot; Supanimit Teekachunhatean

    2012-01-01

    This study was aimed to investigate bioequivalence of modified-release 30 mg gliclazide tablets in 18 healthy Thai volunteers. A test product, Glycon MR (Siam Bheasach, TH), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single-dose, two-treatment, two-period, and two-sequence crossover design in fasted and fed conditions with a washout period of 2 weeks. Blood samples were collected for 72 h after drug administration. Drug plasma concen...

  16. Level of physical activity of physical education students according to criteria of the IPAQ questionnaire and the recommendation of WHO experts

    Directory of Open Access Journals (Sweden)

    Pastuszak Anna

    2014-01-01

    Full Text Available Study aim: Systematic physical activity is an effective preventive measure that supports the preservation of physical health and psychological health. Three expressions employed that relate to the work carried out with MET-min/week as a measure of the level of total physical activity are intense activity, moderate activity, and walking. These were applied to students studying Physical Education. In the process, those who failed to meet the requirements for the ‘sufficient’ level according to IPAQ criteria and as recommended by the WHO were identified.

  17. 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....

  18. 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

  19. 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

  20. 76 FR 26307 - Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug...

    Science.gov (United States)

    2011-05-06

    ... the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA... announced the availability of the draft version of this guidance (74 FR 17872). The public comment period... Bioequivalence Data for Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration,...

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-02-15

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

  2. In vitro dissolution and in vivo bioequivalence evaluation of two brands of trimetazidine tablets.

    Science.gov (United States)

    Helmy, Sally A; Mansour, Noha O

    2014-03-01

    Trimetazidine is an effective anti-anginal agent and anti-ischaemic effect. The objective of this study was to assess the in vitro dissolution and to evaluate the bioavailability of two brands of trimetazidine dihydrochloride tablets. Prior to the in vivo PKs study, an in vitro comparative dissolution test was performed for 2 oral brands of trimetazidine dihydrochloride tablets (20 mg). In vivo PKs study was evaluated in 24 healthy male volunteers after a single dose oral administration in an open, randomized, two-way crossover study with a washout period of 1 week. After an overnight fast, human volunteers were randomly allocated to receive a single dose of either test or reference product. Blood samples were collected over a 24-hour period following drug administration and plasma was analyzed for trimetazidine concentrations using a validated high-performance liquid chromatography assay method. The PK parameters Cmax , AUC0-t , AUC0-∞ , tmax , and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUCt-∞ of the test product over those of reference were within the acceptable range (0.8-1.25) for bioequivalence. As a result, the 2 trimetazidine formulations are considered bioequivalent and thus could be prescribed interchangeably in the medical practice based on its PK effect and biopharmaceutical performance. PMID:27128458

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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...

  8. Recommendations: Radiation protection requirements for organizations engaged in mining activities that can result in the irradiation of employees, the public or the environment

    International Nuclear Information System (INIS)

    The Recommendations are guidelines which are based on applicable laws and regulations, including their most recent amendments. The document contains, in particular, the following articles: General requirements for radiation protection and obligations of the organization, Exposure limits, Systematic radiation protection supervision; Organizational and technical radiation protection provisions; Monitoring, measurement, evaluation and recording of radiation protection-related quantities, parameters and facts; Using the monitoring results, Controlling the irradiation of the personnel and the public; Handling radioactive wastes and material contaminated by natural radionuclides from mining activities, Transport of material emerging from mining activities; Decommissioning of workplaces handling ionizing radiation sources; and Licence applications. (P.A.)

  9. 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

  10. 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

  11. 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...

  12. 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...... topical products. The methods currently available for assessment of BE were reviewed as well as alternatives and the advantages and disadvantages of each method were considered. Guidance on quality and performance of topical products was reviewed and a framework to categorise existing and alternative...... methods for evaluation of BE was discussed. The outcome of the workshop emphasized both a need for greater attention to quality, possibly, via a Quality-By-Design (QBD) approach and a need to develop a "whole toolkit" approach towards the problem of determination of rate and extent in the assessment...

  13. 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…

  14. 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...

  15. 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

  16. Even Apparently Insignificant Chemical Deviations among Bioequivalent Generic Antibiotics Can Lead to Therapeutic Nonequivalence: the Case of Meropenem

    OpenAIRE

    Agudelo, M.; Rodriguez, C. A.; Pelaez, C. A.; Vesga, O.

    2014-01-01

    Several studies with animal models have demonstrated that bioequivalence of generic products of antibiotics like vancomycin, as currently defined, do not guarantee therapeutic equivalence. However, the amounts and characteristics of impurities and degradation products in these formulations do not violate the requirements of the U.S. Pharmacopeia (USP). Here, we provide experimental data with three generic products of meropenem that help in understanding how these apparently insignificant chem...

  17. 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

  18. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

    OpenAIRE

    Jiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald J.; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence X.; Lionberger, Robert

    2015-01-01

    Various health communities have expressed concerns regarding whether average bioequivalence (BE) limits (80.00–125.00%) for the 90% confidence interval of the test-to-reference geometric mean ratio are sufficient to ensure therapeutic equivalence between a generic narrow therapeutic index (NTI) drug and its reference listed drug (RLD). Simulations were conducted to investigate the impact of different BE approaches for NTI drugs on study power, including (1) direct tightening of average BE lim...

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

    OpenAIRE

    Zhou X; Liu J

    2015-01-01

    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. Calculat...

  20. The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE) studies – an overview

    OpenAIRE

    Shaik Mastan; Thirunagari Bhavya Latha; Sathe Ajay

    2011-01-01

    Shaik Mastan1, Thirunagari Bhavya Latha2, Sathe Ajay11Cytel Statistical Software and Services Pvt Ltd, Pune, Maharashtra, India; 2Business Development, Bioserve Clinical Research Pvt Ltd, Hyderabad, Andhra Pradesh, IndiaAbstract: Bioavailability (BA) and bioequivalence (BE) studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. BE is a strategy to introduce generic equivalents of brand...

  1. 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

  2. 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.

  3. The Universal Recommender

    CERN Document Server

    Kunegis, Jérôme; Umbrath, Winfried

    2009-01-01

    We describe the Universal Recommender, a recommender system for semantic datasets that generalizes domain-specific recommenders such a content-based, collaborative, social, bibliographic, lexicographic, hybrid and other recommenders. In contrast to existing recommender systems, the Universal Recommender applies to any dataset that allows a semantic representation. We describe the scalable three-stage architecture of the Universal Recommender and its application to Internet Protocol Television (IPTV). To achieve good recommendation accuracy, several novel machine learning and optimization problems are identified. We finally give a brief argument supporting the need for machine learning recommenders.

  4. 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

  5. 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

  6. 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.

  7. 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)

  8. 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

  9. 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.

  10. 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.

  11. Theoretical Investigation of Dissolution Test Criteria for Waiver of Clinical Bioequivalence Study.

    Science.gov (United States)

    Sugano, Kiyohiko

    2016-06-01

    The purpose of the present study was to provide a theoretical basis for the dissolution test criteria of a biowaiver scheme. The critical dissolution number (Dncrit) was defined as a value to show bioequivalence of AUC and Cmax against infinitely rapid dissolution (Dn = ∞). The gastrointestinal tract was represented by the one-compartment model. The dissolution of a drug was expressed by the Noyes-Whitney equation. The permeation of a drug was expressed by the first-order equation. The approximate analytical solutions of Dncrit were derived from the analytical solution for the fraction of a dose absorbed [Fa = 1 - exp(-1/(1/Dn + Do/Pn)]; Do, the dose number; Pn, the permeation number). Numerical integration was also performed to calculate Dncrit more accurately. Dncrit was found to become smaller as Pn and Do became smaller. Dncrit for Cmax was found to be dependent on the elimination half-life of a drug as well as Pn and Do. The Fa equation can be an appropriate theoretical basis for a biowaiver scheme. PMID:27238491

  12. Rapid LC-MS/MS method for determination of drotaverine in a bioequivalence study.

    Science.gov (United States)

    Vancea, Szende; Gáll, Zsolt; Donáth-Nagy, Gabriella; Borka-Balás, Réka

    2014-09-01

    A liquid chromatography coupled with tandem mass spectrometry method for the quantification of the antispasmodic drug drotaverine in human plasma was developed and validated according to the current bioanalytical guidelines. The internal standard used was imipramine. The separation was performed on a Kinetex C18 50×3mm, 2.6μm column under isocratic conditions using a mobile phase of 65:35 (v/v) formic acid 0.2% (v/v) in water and acetonitrile at 40°C with a flow rate of 0.4ml/min. The detection of drotaverine and the internal standard was performed in multiple reaction monitoring (MRM) mode using an ion trap mass spectrometer with electrospray ionization, operating in positive mode. The human plasma samples (0.24ml) were deproteinized with methanol and aliquots of 4μl from supernatants obtained after centrifugation were directly injected into the chromatographic system. The method shows a good linearity (r(2)>0.997), precision (CV<6.3%) and accuracy (bias<5.4%) over the range of 2.24-448ng/ml drotaverine in plasma. The recovery was between 91 and 98%. The limit of quantification was 2.24ng/ml. The analysis required only a 3.0min run. The developed and validated method for the determination of drotaverine in human plasma was successfully applied in a bioequivalence study, for analyzing approximately 1000 subject's samples. PMID:25005892

  13. Bioequivalence between two commercial formulations of gliclazide in Colombia Bioequivalencia entre dos formulaciones comerciales de gliclazida en Colombia

    Directory of Open Access Journals (Sweden)

    Ignacio Rodríguez

    2001-01-01

    Full Text Available Two commercial formulations of Gliclazide 80 mg tablets were studied in order to evaluate both pharmaceutical and biological equivalence, Glidiab® Tecnoquímicas Laboratories and Diamicron® Euroetika-Elsevier Laboratories. After proving the pharmaceutical equivalence, a bioequivalence was tested in 14 healthy volunteers and the determination of gliclazide in plasma was carried out by high-performance liquid chromatography (HPLC. The evaluated pharmacokinetic parameters were: area under the curve (AUC from 0 to 60 hours, maximum concentration (Cmax and time to maximum concentration (Tmax. In statistical analysis the 90.0% confidence intervals for AUC, Cmax and Tmax, and acceptance range for bioequivalence of 80.0%-125.0% to AUC and Cmax and acceptance range of 80:0%-120.0% to Tmax, were applied. Both formulations presented inter and intra subject high variability and it was found that they are bioequivalent in relation to AUC but they are not bioequivalent in relation to Cmax and Tmax. Los formulaciones comerciales de Gliclazida de 80 mg – tabletas, los productos Glidiab® de Tecnoquímicas y Diamicron® de Euroetika-Elsevier, fueron sometidos a estudio para evaluar la equivalencia farmacéutica y la equivalencia biológica. Después de comprobar la equivalencia farmacéutica se llevó a cabo el estudio de la equivalencia biológica en 14 voluntarios sanos; la cuantificación de Gliclazida en plasma se realizó por la técnica de cromatografía líquida de alta resolución (HPLC. Los parámetros farmacocinéticos evaluados fueron: área bajo la curva (AUC de 0-60 horas, concentración máxima (Cmáx y el tiempo máximo (tmáx los cuales se analizaron estadísticamente con intervalos de confianza del 90.0% y un rango de aceptación para bioequivalencia del 80.0% al 125.0% para AUC y Cmáx y del 80.0% al 120.0% para el tmáx. Ambas formulaciones presentaron alta variabilidad inter e intrasujeto y se encontró que son bioequivalentes con

  14. 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.

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

    International Nuclear Information System (INIS)

    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 C18 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

  16. 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)

  17. Recommender system for selection of touristic advisors

    OpenAIRE

    Levičnik, Andrej

    2013-01-01

    We created a prototype recommender system, advising tourists on tourist guide choice. We examined the area of recommender systems and described two typical approaches to recommender systems design. Our recommender system profiles users based on their activity on social network Facebook. We developed an algorithm for retreival of textual data from Facebook and an algorithm for its exploitation via language technologies. We also used a function for translation of text into vector form using ...

  18. In vitro and in vivo stability of oseltamivir within a bioequivalence trial.

    Science.gov (United States)

    Grigoriev, Alexander; Borisova, Irina; Yaroshenko, Irina; Sidorova, Alla

    2016-05-01

    A simple, precise, and rapid method to simultaneously determine the levels of oseltamivir (OS) and oseltamivir carboxylate (OSC) in human plasma was developed. Additionally, the stability of both substances in plasma was investigated under different conditions. The method involved protein precipitation (0.01 % HCl in acetonitrile), and then the supernatant was injected into the high-performance liquid chromatography (HPLC)-MS/MS. The chromatographic separation was achieved on a YMC-Triart C18 (100 × 2.0 mm, 5 μm) column using acetonitrile/water (30:70, v/v) containing 0.1 % formic acid as the mobile phase. Sample volume was 5 μl. The linearity of the method was established in the concentration range of 0.5-100 ng/mL for OS and 1.0-1000 ng/mL for OSC. The intra-day precision and accuracy for oseltamivir were 1.5-8.9 and 94.4-101.0 %, respectively. For oseltamivir carboxylate, the intra-day precision and accuracy were 3.2-12.7 and 92.8-108.8 %, respectively, whereas the inter-day precision and accuracy were 5.5-11.5 and 94.6-104.0 % for oseltamivir and 4.7-11.5 and 99.9-103.9 % for oseltamivir carboxylate, respectively. The application of this method was demonstrated by a bioequivalence study in 28 healthy humans with 75 mg oseltamivir phosphate capsules (Tamiflu®). Sodium fluoride (2.4 mg/mL) with potassium oxalate (3 mg/mL) was used as anticoagulant within sampling of trial. The assay reproducibility was established by reanalysis of 80 incurred samples. PMID:27002612

  19. Bioequivalence evaluation of two capsule formulations of amoxicillin in healthy adult male bangladeshi volunteers: A single-dose, randomized, open-label, two-period crossover study

    OpenAIRE

    Ullah, Ashik; Azad, Mohammad Abul Kalam; Sultana, Rebeka; Akbor, Maruf Mohammad; Hasan, Ahasanul; Latif, Mahbub; Hasnat, Abul

    2008-01-01

    Background: Amoxicillin, a semisynthetic penicillin antibiotic, is widely prescribed in Bangladesh due to its extended spectrum and its rapid and extensive oral absorption with good tolerability. Although a number of generic oral formulations of amoxicillin are available in Bangladesh, a study of the bioequivalence and pharmacokinetic properties of these formulations has not yet been conducted in a Bangladeshi population.

  20. 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....

  1. 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.

  2. The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE studies – an overview

    Directory of Open Access Journals (Sweden)

    Shaik Mastan

    2011-03-01

    Full Text Available Shaik Mastan1, Thirunagari Bhavya Latha2, Sathe Ajay11Cytel Statistical Software and Services Pvt Ltd, Pune, Maharashtra, India; 2Business Development, Bioserve Clinical Research Pvt Ltd, Hyderabad, Andhra Pradesh, IndiaAbstract: Bioavailability (BA and bioequivalence (BE studies play a major role in the drug development phase for both new drug products and their generic equivalents, and thus attract considerable attention globally. BE is a strategy to introduce generic equivalents of brand-name drugs (innovator drugs to lower the cost of medication through proper assessment as directed by the international regulatory authorities. 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 considerations for conducting BA/BE studies. This article briefly reviews the BA/BE concepts, approaches, designs, and various basic regulatory considerations and prospects for conducting BA/BE studies. Keywords: bioavailability, bioequivalence, generic drugs, regulatory authority, pharmacokinetics, pharmacodynamics 

  3. 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

  4. 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

  5. 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

  6. Analysis of risk factors in human bioequivalence study that incur bioinequivalence of oral drug products.

    Science.gov (United States)

    Yamashita, Shinji; Tachiki, Hidehisa

    2009-01-01

    In the study of human bioequivalence (BE), newly developed oral products sometimes fail to prove BE with a reference product due to the high variability in pharmacokinetic (PK) parameters after oral absorption. In this study, risk factors that incur bioinequivalence in BE study were analyzed by applying the Biopharmaceutics Classification System (BCS). Forty-four generic products were selected from a database of BE studies in the past 10 years at Towa Pharmaceutical Co., Ltd. (Osaka, Japan), and 90% confidence interval (CI) of AUC and C(max) in human BE study for all products were converted into coefficient of variation (CV(90)). Then, the required number of subjects to confirm BE was estimated from the 90% CI in human BE study of new products. It was found that both the permeability of drugs to human intestinal membrane (P(eff)) and the dose number calculated from their water solubility did not correlate well to CV(90) and the estimated subject number in human BE study, suggesting the contribution of other factors to cause the variability in oral drug absorption. As the PK parameter of drugs, the value of AUC/dose was calculated and plotted against CV(90) and the estimated subject number by classifying drugs into 4 BCS classes. For drugs in classes 1 and 3, AUC/dose gave a clear criterion to distinguish the drugs with a high risk of bioinequivalence, where drugs with low AUC/dose showed high CV(90) and large number of subjects. It was suggested that the high metabolic clearance (for class 1 drug) and low oral absorption (for class 3 drug) could be significant factors to incur bioinequivalence in human BE study, although for drugs in classes 2 and 4, clear factors were not defined. Consequently, for drugs in BCS classes 1 and 3, risks in human BE study to incur bioinequivalence could be predicted by calculating the AUC/dose. In the case of generic drugs, since the parameter of AUC/dose is available before initiating human BE study, this finding is expected to

  7. 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

  8. 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....... Compared to four other recommender models (nearest neighbor, two popularity mod- els, random baseline), the archetype based models provide the highest recall rates showing that Archetypal Analysis can be successfully applied for Top-L recommendation purposes...

  9. 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

  10. 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...

  11. Recommending search experiences

    OpenAIRE

    Saaya, Zurina; Smyth, Barry; Coyle, Maurice; Briggs, Peter

    2011-01-01

    In this paper we focus on a multi-case case-based reasoning system to support users during collaborative search tasks. In particular we describe how repositories of search experiences/knowledge can be recommended to users at search time. These recommendations are evaluated using real-world search data.

  12. 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.

  13. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and......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 the...

  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

    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...

  15. 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...

  16. 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.

  17. Collaborative Filtering Recommender Systems

    Directory of Open Access Journals (Sweden)

    Mehrbakhsh Nilashi

    2013-04-01

    Full Text Available Recommender Systems are software tools and techniques for suggesting items to users by considering their preferences in an automated fashion. The suggestions provided are aimed at support users in various decision-making processes. Technically, recommender system has their origins in different fields such as Information Retrieval (IR, text classification, machine learning and Decision Support Systems (DSS. Recommender systems are used to address the Information Overload (IO problem by recommending potentially interesting or useful items to users. They have proven to be worthy tools for online users to deal with the IO and have become one of the most popular and powerful tools in E-commerce. Many existing recommender systems rely on the Collaborative Filtering (CF and have been extensively used in E-commerce .They have proven to be very effective with powerful techniques in many famous E-commerce companies. This study presents an overview of the field of recommender systems with current generation of recommendation methods and examines comprehensively CF systems with its algorithms.

  18. 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.

  19. 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...

  20. Search and Recommendation

    DEFF Research Database (Denmark)

    Bogers, Toine

    2014-01-01

    In just a little over half a century, the field of information retrieval has experienced spectacular growth and success, with IR applications such as search engines becoming a billion-dollar industry in the past decades. Recommender systems have seen an even more meteoric rise to success with wide......-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 are...... more similar than they have been treated in the past decade. By looking more closely at the tasks and problems that search and recommendation try to solve, at the algorithms used to solve these problems and at the way their performance is evaluated, I want to show that there is no clear black and white...

  1. 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...

  2. 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...

  3. Development of a simple LC-MS/MS method for the determination of febuxostat in human plasma and its application to a bioequivalence study.

    Science.gov (United States)

    Shi, Zheng; Liu, Jian; Hu, Xing-Jiang; ShenTu, Jian-Zhong

    2013-06-01

    The purpose of this study was to design a simple, sensitive and rapid liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for a febuxostat bioequivalence study in healthy Chinese male volunteers. In this method, febuxostat and etodolac (internal standard) were isolated from plasma samples by protein precipitation with acetonitrile. The supernatant was chromatographed on a Zorbax SB-C18 (150 x 3.0 mm, 3.5-microm particle size, Agilent) column with a SecurityGuard Inertsil Symmetry C18 column (12.5 x 4.6 mm, 5-microm particle size, Waters). The lower limit of quantification for febuxostat in 0.2 mL of human plasma was 13.40 ng x mL(-1), and the linearity was achieved over a concentration range from 13.40 to 21440 ng x mL(-1). Febuxostat tablets from Hengrui Medicine Co., Ltd (test, Jiangsu, China) and from Takeda pharmaceuticals america, Inc. (reference, Deerfield, IL) were evaluated following a single 80 mg oral dose to 18 healthy volunteers. Bioequivalence was determined by calculating 90% confidence intervals (90% CI) for the ratio of C(max), AUC(0-t), and AUC(0-infinity) values for the test and reference products, using logarithmic transformed data. The calculated 90% CIs for the ratio of C(max) (88.7-131.2%), AUC(0-t) (99.2-122.7%) and AUC(0-infinity) (99.5-123.1%) values for the test and reference products were all located within the bioequivalence criteria range (80-125% for AUC, and 70-143% for Ca(mzax)), proposed by State of Food and Drug Administration [SFDA, 2005. China]. It was concluded that the two febuxostat formulations (test and reference) analyzed were bioequivalent in terms of rate and extent of absorption and the method met the principle of quick and easy clinical analysis. PMID:23875244

  4. Comparison of liquid chromatography-ultraviolet and chromatography-tandem mass spectrometry for the determination of indapamide in human whole blood and their applications in bioequivalence studies.

    Science.gov (United States)

    Zhao, Libo; Gu, Shifen; Xu, Rong; Cui, Xiaoyu; Gan, Fangliang; Chen, Hui

    2010-01-01

    The aim of this study was to compare two methods which were based on liquid chromatography with ultraviolet detection (LC-UV) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), respectively, to determine indapamide (CAS 26807-65-8) and to apply them to bioequivalence studies. The universal parameters, including selectivity, linearity, precision, and quantification limit, served as gold standard for the comparison of the two methods. As a result, the two methods were both very consistent and reliable. Furthermore, the LC-MS/MS method required only one-fifth the blood volume needed by the other method and was approximately 25 times more sensitive than the other method. The total run time of the LC-MS/MS method was 3.5 min per sample as opposed to 11 min for the other method. Forty healthy male Chinese volunteers were selected as subjects. One half were orally administrered 2.5 mg indapamide immediate release tablets while the other half were orally administered 1.5 mg indapamide sus-tained release coated tablets. The collected blood samples were determined with the two methods described above. The pharmacokinetic parameters were determined using a noncompartmental method. For the bioequivalence studies, the pharmacokinetic parameters acquired here were in line with the literature and parameters met the criteria set by the State Food and Drug Administration of China (SFDA) for bioequivalence study, indicating that generic drugs are bioequivalent to branded drugs. The present study suggests that the two methods based on LC-UV and LC-MS/MS were suitable for bioavailability studies of indapamide with different pharmaceutical formulations. Consequently, it can be believed that the criterion that each individual expected concentration range would need a given bioassay with the requested sensitivity is not absolutely right. In practice, most of the time, the highest sensitivity allows to bioassay concentrations in a higher range. PMID:20712133

  5. 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.

  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. 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

  8. 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.

  9. 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.

  10. Development of a simple LC-MS/MS method for determination of rebamipide in human plasma and its application to a bioequivalence study.

    Science.gov (United States)

    Liu, Jian; Shen-Tu, Jianzhong; Wu, Lihua; Dou, Jing; Xu, Qiyang; Zhou, Huili; Wu, Guolan; Hu, Xingjiang

    2012-11-01

    The purpose of this study was to design a simple and rapid liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for a rebamipide bioequivalence study in healthy Chinese male volunteers. In this method, sample pretreatment involved simple protein precipitation with venlafaxine as the internal standard. Analysis was achieved on a ZORBAX SB-C18 column with a concentration range of 6-1200 ng/mL. Rebamipide tablets from Yuanlijian (test, Hangzhou, China) and from Otsuka (reference, Hangzhou, China) were evaluated following a single 300 mg oral dose to 20 healthy volunteers. Bioequivalence was determined by calculating 90% confidence intervals (90% CI) for the ratio of Cmax, AUC(0-t) and AUC(0-infinity) values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals for the ratio of Cmax (83.7-118.4%), AUC(0-t) (91.1-113.4%) and AUC(0-infinity) (90.6-113.2%) values for the test and reference products were within the interval (80.0-125.0% for AUC, and 70-143% for Cmax), proposed by State of Food and Drug Administration [SFDA, 2005. China]. It was concluded that the two rebamipide tablets were bioequivalent in their rate and extent of absorption and the method met the principle of quick and easy clinical analysis. PMID:23210239

  11. 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.

  12. 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.

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

    Science.gov (United States)

    Tsume, Yasuhiro; Amidon, Gordon L

    2010-08-01

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

  14. 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.

  15. A Consensus-Focused Group Recommender System

    OpenAIRE

    Ioannidis, Stratis; Muthukrishnan, S.; Yan, Jinyun

    2013-01-01

    In many cases, recommendations are consumed by groups of users rather than individuals. In this paper, we present a system which recommends social events to groups. The system helps groups to organize a joint activity and collectively select which activity to perform among several possible options. We also facilitate the consensus making, following the principle of group consensus decision making. Our system allows users to asynchronously vote, add and comment on alternatives. We observe soci...

  16. 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)

  17. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.

    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...... regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for...... will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact....

  18. 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...

  19. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-04-08

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised,...

  20. 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...

  1. 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

  2. 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

  3. 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…

  4. 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

  5. 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...

  6. Physical Activity of Male and Female Adolescents Living in a Town and a City in the Context of Public Health Recommendations

    Science.gov (United States)

    Mynarski, Wladyslaw; Nawrocka, Agnieszka; Rozpara, Michal; Garbaciak, Wieslaw

    2012-01-01

    Study aim: To assess the physical activity of male and female adolescents from Poland living in a town (Czechowice-Dziedzice) and in a city (Katowice). Material and methods: The research involved 431 high school students aged 16-18 years (249 from Czechowice-Dziedzice and 182 from Katowice). Physical activity was measured by the short form of the…

  7. 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.

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

    Directory of Open Access Journals (Sweden)

    Dinesh S. Patel

    2012-10-01

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

  9. 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.

  10. 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.

  11. 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.

  12. 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...

  13. 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

  14. 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 ...

  15. 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

  16. Waste management safeguards project: History of and recommendations for development activities in support of safeguards of final disposal of spent fuel

    International Nuclear Information System (INIS)

    Coordinated safeguards assessment and development activities in support of the U.S. Civilian Radioactive Waste Management System (CRWMS) and international safeguards objectives were initiated in Fiscal Year 1987. Initial technical support activities were performed at the direction of the U.S. Department of Energy (DOE) Office of Civilian Radioactive Waste Management (OCRWM); however, as the priority of support activities changed, direction for the support tasks was transferred to the U.S. Department of State (State), the DOE Office of Arms Control and Nonproliferation (DOE/IS-40), and the U.S. Nuclear Regulatory Commission (NRC). The direction for technical support activities was established at the International Atomic Energy Agency's (IAEA's) advisory group meeting and subsequent consultants' meetings on safeguards related to the final disposal of nuclear material contained in waste and spent fuel. Task directions for the development of international safeguards in support of the final disposal of spent fuel are currently being provided by DOE/IS-40. A summary of safeguards activities performed by the Waste Management Safeguards Project is provided. Systems for design information verification for spent fuel consolidation and conditioning operations are needed immediately. Safeguards approaches for maintaining continuity of knowledge of spent fuel processed at the conditioning facility and for verification of the final disposal package will be needed within three years. Systems for design information verification of the repository facilities will be needed by the end of the decade

  17. 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.

  18. 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…

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

    OpenAIRE

    Suhas S Khandave; Sawant, Satish V; Santosh S Joshi; et al.

    2010-01-01

    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 tramado...

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

    Science.gov (United States)

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

    2013-11-01

    To evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (CAS 82248-59-7) capsules (test) and an available branded capsules (reference) after administration of a single 40 mg dose, randomized, open-label, 2-period crossover study was conducted in 22 healthy male Chinese subjects with a 1-week wash-out period. This study was designed for/the Honglin Pharmaceutical Co. Ltd and contracted to be done by the Beijing Anding Hospital in order to satisfy Chinese regulatory requirements to allow marketing of this generic product and performed according to the criteria of SFDA. Blood samples were collected before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and 24 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detection. A non-compartmental method was used to calculate the pharmacokinetic parameters and evaluate bioequivalence of the 2 formulations. The 90% confidence interval (CI) of the ratios (test/reference) of atomoxetine for AUC0-24, AUC0-∞ and Cmax were 100.9% (93.6-108.8%), 103.1% (95.1-111.7%) and 105.2% (92.8-119.4%), respectively, which fell within the interval of 80-125% and 75-133%. No clinically significant changes or abnormalities were noted in laboratory data and vital signs. From these results it can be concluded that the test formulation of atomoxetine capsules met the regulatory criterion for bioequivalence to the reference formulation. PMID:23812961

  1. 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.

  2. 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.

  3. 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.

  4. Bioequivalencia entre dos formulaciones de claritromicina en suspensión pediátrica existentes en el mercado chileno Bioequivalence evaluation of two brands of clarithromycin suspension available in the Chilean pharmacopeia

    Directory of Open Access Journals (Sweden)

    LEONARDO GAETE G

    2003-01-01

    committee. None of the pharmacokinetic parameters such as peak plamatic level (Cmáx, half-live (t1/2, area under the curve of plasmatic levels vs time, from 0 to inifinity (ABC0-¥ and velocity rate constant (Kabs, showed significant differences for both products. According to the guidelines recommended by the FDA and by means of our findings, we can assure that Pre-Clar® and Klaricid® in suspension are bioequivalents. Therefore, we may assume that both products are interchangeable without compromising clinical efficacy.

  5. 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...

  6. 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.

  7. 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.

  8. A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States

    OpenAIRE

    Gadiko, Chaitanya; Tippabhotla, Sudhakar Koundinya; Thota, Satyanarayana; Battula, Ramakrishna; Khan, Sohel Md.; Vobalaboina, Venkateswarlu

    2013-01-01

    To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples were collected up to 72 h post-dose and plasma samples were analyzed for donepezil using a validated L...

  9. 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...

  10. 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...

  11. 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.

  12. 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...

  13. 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.

  14. AN EFFECTIVE RECOMMENDATIONS BY DIFFUSION ALGORITHM FOR WEB GRAPH MINING

    OpenAIRE

    S. Vasukipriya; T. Vijaya Kumar

    2013-01-01

    The information on the World Wide Web grows in an explosive rate. Societies are relying more on the Web for their miscellaneous needs of information. Recommendation systems are active information filtering systems that attempt to present the information items like movies, music, images, books recommendations, tags recommendations, query suggestions, etc., to the users. Various kinds of data bases are used for the recommendations; fundamentally these data bases can be molded in the form of man...

  15. 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

  16. 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.

  17. Novel fenofibric acid-loaded controlled release pellet bioequivalent to choline fenofibrate-loaded commercial product in beagle dogs.

    Science.gov (United States)

    Kim, Kyung Soo; Jin, Sung Giu; Mustapha, Omer; Yousaf, Abid Mehmood; Kim, Dong Wuk; Kim, Young Hun; Kim, Jong Oh; Yong, Chul Soon; Woo, Jong Soo; Choi, Han-Gon

    2015-07-25

    The objective of this study was to develop a novel fenofibric acid-loaded controlled release pellet showing enhanced, or equivalent to, bioavailability compared with two commercially available products containing fenofibrate or choline fenofibrate. The effect of solubilizing agents on drug solubility and the impact of fillers on core properties were investigated. Among them, magnesium carbonate most improved drug solubility, and κ-carrageenan provided the best spherical cores. The fenofibric acid-loaded pellet was prepared with magnesium carbonate and κ-carrageenan employing the extrusion/spheronizing technique followed by coating with ethylcellulose. Furthermore, dissolution and pharmacokinetic study in beagle dogs were performed compared to the fenofibrate-loaded commercial tablet (FCT) and choline fenofibrate-loaded commercial mini-tablet (CFCM). This fenofibric acid-loaded pellet showed controlled release of the drug in phosphate buffer (pH 6.8) and 0.025 M sodium laurylsulfate within 4h. Furthermore, this pellet and CFCM exhibited similar dissolution profiles. Plasma concentrations greater than 1,000 ng/ml were maintained from 30 min to 8h, suggesting a sustained release pattern. Also, the fenofibric acid-loaded pellet gave significantly higher AUC and Cmax values than FCT, indicating that it improved the bioavailability of fenofibrate due to enhanced solubility and sustained release. In addition, this pellet and CFCM were not significantly different in terms of pharmacokinetic parameters including AUC, Cmax and Tmax. Thus, this pellet was bioequivalent to CFCM in beagle dogs. In conclusion, this fenofibric acid-loaded controlled release pellet would be a potential alternative to the choline fenofibrate-loaded commercial product. PMID:26024820

  18. 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.

  19. On Imprecise Investment Recommendations

    Directory of Open Access Journals (Sweden)

    Piasecki Krzysztof

    2014-08-01

    Full Text Available The return rate is considered here as a fuzzy probabilistic set. Then the expected return is obtained as a fuzzy subset in the real line. This result is a theoretical foundation for new investment strategies. All considered strategies result of comparison profit fuzzy index and limit value. In this way we obtain an imprecise investment recommendation. Financial equilibrium criteria are a special case of comparison of the profit index and the limit value. The following criteria are generalized here: the Sharpe's Ratio, the Jensen's Alpha and the Treynor's Ratio. Moreover, the safety-first criteria are generalized here for the fuzzy case. The Roy Criterion, the Kataoka Criterion and the Telser Criterion are also generalized. Obtained results show that proposed theory is useful for the investment applications.

  20. 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.

  1. Resumes and recommendations

    International Nuclear Information System (INIS)

    Dose-response relationships for patients and personnel under radiotherapeutic procedures are considered. It is shown, that for most tissues and bodies a threshold dose for normal function injury exists. The threshold dose for tissue tolerance in patients which have undergone standard fractionated radiotherapy, is lower than the dose which might cause a comparable injury under sufficiently higher effect prolongation typical for occupational exposure. With appropriate corrections being introduced, dose equivalent limits, which are currently recommended create a reliable safety reserve for all tissues (except for bone marrow, gonads and eye lens). Safety limits for gonads, testes, ovaries, eye lens and bone marrow are considered. Attention is paid to LET effect on radiation as well as to dose limits for population individuals

  2. IRIS Product Recommendations

    Science.gov (United States)

    Short, David A.

    2000-01-01

    This report presents the Applied Meteorology Unit's (AMU) evaluation of SIGMET Inc.'s Integrated Radar Information System (IRIS) Product Generator and recommendations for products emphasizing lightning and microburst tools. The IRIS Product Generator processes radar reflectivity data from the Weather Surveillance Radar, model 74C (WSR-74C), located on Patrick Air Force Base. The IRIS System was upgraded from version 6.12 to version 7.05 in late December 1999. A statistical analysis of atmospheric temperature variability over the Cape Canaveral Air Force Station (CCAFS) Weather Station provided guidance for the configuration of radar products that provide information on the mixed-phase (liquid and ice) region of clouds, between 0 C and -20 C. Mixed-phase processes at these temperatures are physically linked to electrification and the genesis of severe weather within convectively generated clouds. Day-to-day variations in the atmospheric temperature profile are of sufficient magnitude to warrant periodic reconfiguration of radar products intended for the interpretation of lightning and microburst potential of convectively generated clouds. The AMU also examined the radar volume-scan strategy to determine the scales of vertical gaps within the altitude range of the 0 C to -20 C isotherms over the Kennedy Space Center (KSC)/CCAFS area. This report present's two objective strategies for designing volume scans and proposes a modified scan strategy that reduces the average vertical gap by 37% as a means for improving radar observations of cloud characteristics in the critical 0 C to -20 C layer. The AMU recommends a total of 18 products, including 11 products that require use of the IRIS programming language and the IRIS User Product Insert feature. Included is a cell trends product and display, modeled after the WSR-88D cell trends display in use by the National Weather Service.

  3. Urgent recommendation. Interim report

    International Nuclear Information System (INIS)

    The Investigation Committee for Critical Accident at Uranium Processing Plant was founded immediately after the accident to investigate the cause of the accident and to establish measures to prevent the similar accident. On September 30, 1999 around 10:35, the Japan's first criticality accident occurred at JCO Co. Ltd. Uranium processing plant (auxiliary conversion plant) located at Tokai-mura Ibaraki-ken. The criticality continued on and off for approximately 20 hours after the first instantaneous criticality. The accident led the recommendation of tentative evacuation and sheltering indoors for residents living in the neighborhood. The serious exposure to neutrons happened to three workers. The dominant effect is dose due to neutrons and gamma rays from the precipitation tank. When the accident took place, three workers dissolved sequentially about 2.4 kg uranium powder with 18.8 % enrichment in the 10-litter bucket with nitric acid. The procedure of homogenization of uranium nitrate was supposed to be controlled using the shape-limited narrow storage column. Actually, however, the thick and large precipitation tank was used. As a result, about 16.6 kg of uranium was fed into the tank, which presumably caused criticality. The first notification by JCO was delayed and the following communication was not smooth. This led to the delay of correct understanding of the situation and made the initial proper response difficult, then followed by insufficient communication between the nation, prefecture, and local authority. Urgent recommendations were made on the following items; (1) Safety measures to be taken at the accident site, (2) health cares for residents and others, (3) Comprehensive safety securing at nuclear operators such as Establishment of the effective audit system, Safety education for employees and Qualification and licensing system, Safety related documents, etc. (4) Reconstruction of the government's safety regulations such as How safety regulation

  4. 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...

  5. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management.

    Science.gov (United States)

    Misra, A; Chowbey, P; Makkar, B M; Vikram, N K; Wasir, J S; Chadha, D; Joshi, Shashank R; Sadikot, S; Gupta, R; Gulati, Seema; Munjal, Y P

    2009-02-01

    Asian Indians exhibit unique features of obesity; excess body fat, abdominal adiposity, increased subcutaneous and intra-abdominal fat, and deposition of fat in ectopic sites (liver, muscle, etc.). Obesity is a major driver for the widely prevalent metabolic syndrome and type 2 diabetes mellitus (T2DM) in Asian Indians in India and those residing in other countries. Based on percentage body fat and morbidity data, limits of normal BMI are narrower and lower in Asian Indians than in white Caucasians. In this consensus statement, we present revised guidelines for diagnosis of obesity, abdominal obesity, the metabolic syndrome, physical activity, and drug therapy and bariatric surgery for obesity in Asian Indians after consultations with experts from various regions of India belonging to the following medical disciplines; internal medicine, metabolic diseases, endocrinology, nutrition, cardiology, exercise physiology, sports medicine and bariatric surgery, and representing reputed medical institutions, hospitals, government funded research institutions, and policy making bodies. It is estimated that by application of these guidelines, additional 10-15% of Indian population would be labeled as overweight/obese and would require appropriate management. Application of these guidelines on countrywide basis is also likely to have a deceleration effect on the escalating problem of T2DM and cardiovascular disease. These guidelines could be revised in future as appropriate, after another large and countrywide consensus process. Till that time, these should be used by clinicians, researchers and policymakers dealing with obesity and related diseases. PMID:19582986

  6. A rapid and simple UPLC-MS-MS method for determination of glipizide in human plasma and its application to bioequivalence study.

    Science.gov (United States)

    Qiu, Xiangjun; Zheng, Shuang-li; Wang, Yingfei; Wang, Rong; Ye, Lei

    2015-01-01

    In this study, a simple, rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry method is described for the determination of glipizide in human plasma samples using carbamazepine as the internal standard (IS) from bioequivalence assays. Sample preparation was accomplished through protein precipitation with methanol, and chromatographic separation was performed on an Acquity BEH C18 column (2.1 mm × 50 mm, 1.7 μm) with gradient profile at a flow rate of 0.4 mL/min. Mass spectrometric analysis was performed using an QTrap5500 mass spectrometer coupled with an electrospray ionization source in the positive ion mode. The multiple reaction monitoring transitions of m/z 446.1 → 321.0 and m/z 237.1 → 194.2 were used to quantify for glipizide and IS. The linearity of this method was found to be within the concentration range of 10-1,500 ng/mL for glipizide in human plasma. Only 1.0 min was needed for an analytical run. The method was applied to a bioequivalence study of two drug products containing glipizide in human plasma samples. PMID:24771054

  7. 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

  8. Urgent recommendation. Interim report

    Energy Technology Data Exchange (ETDEWEB)

    Nakano, Masayuki [International Affairs and Safeguards Division, Atomic Energy Bureau, Science and Technology Agency, Tokyo (Japan)

    2000-12-01

    The Investigation Committee for Critical Accident at Uranium Processing Plant was founded immediately after the accident to investigate the cause of the accident and to establish measures to prevent the similar accident. On September 30, 1999 around 10:35, the Japan's first criticality accident occurred at JCO Co. Ltd. Uranium processing plant (auxiliary conversion plant) located at Tokai-mura Ibaraki-ken. The criticality continued on and off for approximately 20 hours after the first instantaneous criticality. The accident led the recommendation of tentative evacuation and sheltering indoors for residents living in the neighborhood. The serious exposure to neutrons happened to three workers. The dominant effect is dose due to neutrons and gamma rays from the precipitation tank. When the accident took place, three workers dissolved sequentially about 2.4 kg uranium powder with 18.8 % enrichment in the 10-litter bucket with nitric acid. The procedure of homogenization of uranium nitrate was supposed to be controlled using the shape-limited narrow storage column. Actually, however, the thick and large precipitation tank was used. As a result, about 16.6 kg of uranium was fed into the tank, which presumably caused criticality. The first notification by JCO was delayed and the following communication was not smooth. This led to the delay of correct understanding of the situation and made the initial proper response difficult, then followed by insufficient communication between the nation, prefecture, and local authority. Urgent recommendations were made on the following items; (1) Safety measures to be taken at the accident site, (2) health cares for residents and others, (3) Comprehensive safety securing at nuclear operators such as Establishment of the effective audit system, Safety education for employees and Qualification and licensing system, Safety related documents, etc. (4) Reconstruction of the government's safety regulations such as How safety

  9. Site Recommendation Subsurface Layout

    Energy Technology Data Exchange (ETDEWEB)

    C.L. Linden

    2000-06-28

    The purpose of this analysis is to develop a Subsurface Facility layout that is capable of accommodating the statutory capacity of 70,000 metric tons of uranium (MTU), as well as an option to expand the inventory capacity, if authorized, to 97,000 MTU. The layout configuration also requires a degree of flexibility to accommodate potential changes in site conditions or program requirements. The objective of this analysis is to provide a conceptual design of the Subsurface Facility sufficient to support the development of the Subsurface Facility System Description Document (CRWMS M&O 2000e) and the ''Emplacement Drift System Description Document'' (CRWMS M&O 2000i). As well, this analysis provides input to the Site Recommendation Consideration Report. The scope of this analysis includes: (1) Evaluation of the existing facilities and their integration into the Subsurface Facility design. (2) Identification and incorporation of factors influencing Subsurface Facility design, such as geological constraints, thermal loading, constructibility, subsurface ventilation, drainage control, radiological considerations, and the Test and Evaluation Facilities. (3) Development of a layout showing an available area in the primary area sufficient to support both the waste inventories and individual layouts showing the emplacement area required for 70,000 MTU and, if authorized, 97,000 MTU.

  10. 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 ...

  11. 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

  12. 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

  13. 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...

  14. QEIP Evaluation - Results & Recommendations

    OpenAIRE

    Stubbé-Alberts, H.E.; Corbalan Perez, G.

    2014-01-01

    In 2010 War Child Holland (WCH) started a program aimed at improving the quality of education in governmental primary schools in Northern Uganda and Karamoja sub-region - Quality Education Improvement Plan (QEIP). QEIP uses a community based approach, involving all school stakeholders, with the aim to increase relevance and sustainability by putting the ownership of the activity with the children, school, community, local leaders and district. Through improving the quality of education and en...

  15. Recommendation Sets and Choice Queries

    DEFF Research Database (Denmark)

    Viappiani, Paolo Renato; Boutilier, Craig

    the problem of generating optimal recommendation sets and the problem of generating optimal choice queries, considering both Bayesian and regret-based elicitation. Our results show that, somewhat surprisingly, under very general circumstances, the optimal recommendation set coincides with the optimal......Utility elicitation is an important component of many applications, such as decision support systems and recommender systems. Such systems query users about their preferences and offer recommendations based on the system's belief about the user's utility function. We analyze the connection between...... query....

  16. 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

  17. 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.

  18. 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.

  19. 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

  20. Radiological protection principles to be applied to land areas radioactively contaminated by uranium mining activities, and intended to be used for forestry or agriculture, or as a landscape facility (park) or as a residential area. 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 radioactive contamination measured on operating grounds, at uranium ore loading points, and along transportation routes. The Recommendation involves the use of these areas for forestry or agriculture, landscape facilities (parks), or as residential areas (and comparable types of use, as e.g. for schools, nursery schools, office buildings). The maximum permissible, specific activities are defined in order to provide protection of the population from the hazards of radioactivity. (orig./HP)

  1. 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.

  2. 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.

  3. 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 ...

  4. 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...... towards achieving a greater link between micronutrient recommendations and behaviour. This study aims to examine the rationale and processes associated with consumer and stakeholder involvement in setting micronutrient recommendations across Europe. Subjects/Methods: Using the contacts established through...... the Eurreca network of excellence (commissioned by the European Commission), the research involved in-depth desk research of key documents and communication channels linked to the process of setting micronutrient recommendations across seven countries: the United Kingdom, Norway, Denmark, Germany...

  5. 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.

  6. 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.

  7. 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

  8. 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...

  9. 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,...

  10. 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...

  11. 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...

  12. Chapter 6: Conclusions and recommendations

    International Nuclear Information System (INIS)

    This chapter provides a brief summary of conclusions with respect to project implementation issues. Furthermore, the chapter contains recommendations on future applications of the modelling system and on water resources management in the project area

  13. 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.

  14. 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...

  15. 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.

  16. 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...

  17. 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

  18. 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.

  19. 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...

  20. Recommended Practices in Thrust Measurements

    Science.gov (United States)

    Polk, James E.; Pancotti, Anthony; Haag, Thomas; King, Scott; Walker, Mitchell; Blakely, Joseph; Ziemer, John

    2013-01-01

    Accurate, direct measurement of thrust or impulse is one of the most critical elements of electric thruster characterization, and one of the most difficult measurements to make. The American Institute of Aeronautics and Astronautics has started an initiative to develop standards for many important measurement processes in electric propulsion, including thrust measurements. This paper summarizes recommended practices for the design, calibration, and operation of pendulum thrust stands, which are widely recognized as the best approach for measuring micro N- to mN-level thrust and micro Ns-level impulse bits. The fundamentals of pendulum thrust stand operation are reviewed, along with its implementation in hanging pendulum, inverted pendulum, and torsional balance configurations. Methods of calibration and recommendations for calibration processes are presented. Sources of error are identified and methods for data processing and uncertainty analysis are discussed. This review is intended to be the first step toward a recommended practices document to help the community produce high quality thrust measurements.

  1. 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)

  2. 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.

  3. TOURISM RECOMMENDATION SYSTEM: EMPIRICAL INVESTIGATION

    Directory of Open Access Journals (Sweden)

    Biljana PETREVSKA

    2012-12-01

    Full Text Available The paper makes an attempt to justify the necessity of implementing recommendation system which will assist tourists in identification of their ideal holiday. The proposed recommendation system based on collaborative filtering notes positive impulses in the case of Macedonia. A software module is developed being capable to generate a personalized list of favorable and tailor-made items. The research outcomes indicate that the designed national tourism web portal can provide satisfactory performance and may be of high importance to all key-tourism actors in the process of identifying measures necessary for creating competitive tourism product.

  4. Personalization techniques and recommender systems

    CERN Document Server

    Uchyigit, Gulden

    2008-01-01

    The phenomenal growth of the Internet has resulted in huge amounts of online information, a situation that is overwhelming to the end users. To overcome this problem, personalization technologies have been extensively employed. The book is the first of its kind, representing research efforts in the diversity of personalization and recommendation techniques. These include user modeling, content, collaborative, hybrid and knowledge-based recommender systems. It presents theoretic research in the context of various applications from mobile information access, marketing and sales and web services,

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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%

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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.

  2. Bioanalytical method development and validation of alimemazine in human plasma by LC-MS/MS and its application in bioequivalence studies

    Directory of Open Access Journals (Sweden)

    Bhupinder Singh

    2013-01-01

    Full Text Available Background: The use of anti-histaminic agents has been increased significantly from last decades and till now no method is available for quantitation of ALZ in human plasma which can be applied in a bioequivalence study using LC-MS/MS. Objective: The present study is concerned with the development and validation of ALZ in human plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS. Materials and Methods: Sample preparation involved the extraction with liquid-liquid extraction method by using ethyl acetate as an organic solvent. Chromatographic separation was performed on Atlantis; T3 5 ΅m 4.6 mm Χ 150 mm column with the mobile phase consisting of acetonitrile: (10 mm ammonium formate buffer: Formic acid: 99.9:00.1 v/v 50:50 v/v. The interface used with the application programming interface 4000 LC-MS/MS was a turbo ion spray in which positive ions were measured in multiple reaction monitoring mode. The precursor to product ions transition of m/z 299.30 → 100.20 amu and 305.30 → 106.30 amu were used for ALZ and ALZ D6 respectively. Results: The method was validated over the concentration range of 20.013-10006.551 pg/mL. The mean percent recovery of ALZ was found 77.771% with a precision of 7.71% and the lower limit of quantification was 20.013 pg/mL. The intra- and inter-day precision of the method at three concentrations was 0.98-4.50% and 1.57-5.72% while the intra- and inter-day % accuracy was 99.02-93.82% and 101.78-106.96%. Stability of compounds was established in a series of stability studies. The application of this method was demonstrated in the bioequivalence study and was found suitable in a study of sample size as big as 30 enrolled volunteers. Conclusion: For the very first time, a sensitive, selective and robust Liquid Chromatography- Mass Spectrometry method for the determination of alimemazine (ALZ in human plasma has been developed and validated using ALZ D6 as an internal standard.

  3. 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.

  4. 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.

  5. Recommended Guidelines for PKU Programs.

    Science.gov (United States)

    Children's Bureau (DHEW), Washington, DC.

    A discussion of screening tests for phenylketonuria recommends and provides some data on two tests, lists five disadvantages of urine tests, and discusses three new tests. Also considered are the role of the central laboratory facility and seven suggestions for screening different types of infants at different times. Treatment or followup programs…

  6. 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

  7. 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.

  8. 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

  9. Recommendations for pediatric tuberculosis vaccination in Italy.

    Science.gov (United States)

    Montagnani, Carlotta; Esposito, Susanna; Galli, Luisa; Chiappini, Elena; Principi, Nicola; de Martino, Maurizio

    2016-03-01

    Bacillus Calmette-Guérin (BCG) vaccine is still the only vaccine approved for the prevention of tuberculosis (TB), and is widely used in highly endemic countries, where all newborns receive a single intradermal dose immediately after birth; however, the recommendations concerning its use in Europe vary widely from country to country. This document describes the recommendations of a group of Italian scientific societies concerning its pediatric use in Italy, the persistence of the protection it provides, its safety, its interference with tuberculin skin test (TST) responses, and the children who should be vaccinated. The experts conclude that BCG vaccination provides a good level of protection against tuberculous meningitis and disseminated forms, and a fair level of protection against pulmonary disease; the protective effective lasts at least 10 years, and revaccination offers no advantages over a single administration. The vaccine is safe in immunocompetent subjects, and affects the response to a TST for at least 6 y On the basis of these observations, we recommend its use in Italy in all TST-negative immunocompetent newborns and breastfeeding infants aged <6 months, and all TST-negative children aged between 6 months and 5 y who come from highly epidemic areas, or whose parents come from highly endemic areas, or who have been in contact with a family member with active TB without contracting the disease themselves. PMID:26587764

  10. 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...

  11. Respectful doubts on the new ICRP recommendations

    International Nuclear Information System (INIS)

    The admiration and deference an International Organization, as ICRP, deserves not only by its altruistic mission but also by the eminent and distinguished scientists who work for it, in some way 'dazzles' to simple students of its theories and, in some way 'force' us to accept, sometimes without any critical, serious and previous meditation, its recommendations. But it is not the bad thing this kind of 'blindness' we have before the almighty ...ICRP dixit..., the worst thing is that non-specialist and non-specialized persons believe as 'dogmas' and 'axioms' the ICRP recommednations and make of them legal dispositions through standards and regulations. Standards an regulations which can frustate an industrial or any other type of peaceful nuclear activity due to the economic or the social reasons derived from ICRP recommendations. The inflexibility (weakened in the arguments but strengthened in the recommendations) of this influent Organism on the 'linearity without threshold' in the dose-effect relationship and the compromises of the International Labor Organization (ILO) with respect ICRP recommedations provole irrational, ilogical and non desirable answers. (author)

  12. 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.

  13. AN EFFECTIVE RECOMMENDATIONS BY DIFFUSION ALGORITHM FOR WEB GRAPH MINING

    Directory of Open Access Journals (Sweden)

    S. Vasukipriya

    2013-04-01

    Full Text Available The information on the World Wide Web grows in an explosive rate. Societies are relying more on the Web for their miscellaneous needs of information. Recommendation systems are active information filtering systems that attempt to present the information items like movies, music, images, books recommendations, tags recommendations, query suggestions, etc., to the users. Various kinds of data bases are used for the recommendations; fundamentally these data bases can be molded in the form of many types of graphs. Aiming at provided that a general framework on effective DR (Recommendations by Diffusion algorithm for web graphs mining. First introduce a novel graph diffusion model based on heat diffusion. This method can be applied to both undirected graphs and directed graphs. Then it shows how to convert different Web data sources into correct graphs in our models.

  14. 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.

  15. 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.

  16. Testing interface with utilities: problems and recommendations

    International Nuclear Information System (INIS)

    The start-up test program occurs at a time of high completion construction activity, maximum effort to accomplish training of operators, and at a time when fewest knowledgeable people are available to develop procedures. The onset of testing places test equipment calibration burdens on an untried instrumentation shop, operational control burdens on a new plant staff, sudden actuation of a utility and NSSS Test organization. Unless carefully thought out well ahead of time, plant delays and improper testing can occur. The paper identifies problem areas and makes recommendations for improvement

  17. Recommendations from EPA's review committee on WIPP

    International Nuclear Information System (INIS)

    The Environmental Protection Agency's National Advisory Council for Environmental Policy and Technology (NACEPT) Subcommittee on WIPP was asked by EPA for advice concerning three issues relevant to the promulgation of 40 CFR 194, the Criteria for Certification of WIPP's compliance with the standards, 40 CFR Part 191. These issues are: (1) passive institutional controls (PICs), including markers at the site and record keeping intended to reduce the likelihood of inadvertent human intrusion, (2) the starting date for purposes of establishing release limits for WIPP, and (3) peer review of activities relating to WIPP compliance and safety. The NACEPT Subcommittee's recommendations and the reasons for them are summarized

  18. Automatic home medical product recommendation.

    Science.gov (United States)

    Luo, Gang; Thomas, Selena B; Tang, Chunqiang

    2012-04-01

    Web-based personal health records (PHRs) are being widely deployed. To improve PHR's capability and usability, we proposed the concept of intelligent PHR (iPHR). In this paper, we use automatic home medical product recommendation as a concrete application to demonstrate the benefits of introducing intelligence into PHRs. In this new application domain, we develop several techniques to address the emerging challenges. Our approach uses treatment knowledge and nursing knowledge, and extends the language modeling method to (1) construct a topic-selection input interface for recommending home medical products, (2) produce a global ranking of Web pages retrieved by multiple queries, and (3) provide diverse search results. We demonstrate the effectiveness of our techniques using USMLE medical exam cases. PMID:20703712

  19. 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

  20. 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

  1. Evaluation of comparative performance of orally inhaled drug products in view of the classical bioequivalence paradigms: an analysis of the current scientific and regulatory dilemmas of inhaler evaluation.

    Science.gov (United States)

    Horhota, Stephen T

    2014-12-01

    Since the early 1960s, there has been a continuous evolution in scientific understanding regarding bioequivalence (BE) of oral dosage forms, intermittently punctuated by some breakthrough research findings and conceptual advances. The accumulated knowledge from this body of research has been translated into a sophisticated risk management framework of regulations and guidelines supported by an extensive set of tools and decision rules. This has permitted us to arrive at a state that now allows, in the majority of cases, not only the unrestricted substitution of a generic product for the innovator version, but also unquestioned substitution between different generic manufacturers. This framework has been successfully extended or adapted to go beyond oral dosage forms to include, for example, topical semisolid applications and nasal sprays. In the case of orally inhaled locally acting drug products (OIP), a similar level of success has yet to be realized. For OIP's, the risk management toolbox is incompletely outfitted due to missing science, knowledge, and experience in some key areas. This article presents a gap analysis of the situation highlighting unresolved residual risks. Assessment of the residual risks by US and EU medicines authorities has interestingly led to different regulatory positions with respect to BE for this class of drug products in these two regions. A parallel comparison with the history for BE of oral dosage forms shows that resolution for inhaled products will come eventually with the final outcome and timeframe, depending as much on science as it does on economics and the degree to which legislators intervene. PMID:25237840

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. Rapid high performance liquid chromatographic method for determination of clarithromycin in human plasma using amperometric detection: application in pharmacokinetic and bioequivalence studies.

    Science.gov (United States)

    Foroutan, Seyed Mohsen; Zarghi, Afshin; Shafaati, Alireza; Madadian, Babak; Abolfathi, Farshid

    2013-01-01

    A rapid, sensitive and reproducible HPLC method using amperometric detector was developed and validated for the analysis of clarithromycin in human plasma. The separation was achieved on a monolithic silica column (MZ- C8 125×4.0 mm) using acetonitrile-methanol-potassium dihydrogen phosphate buffer (40:6:54,v/v), with pH of 7.5, as the mobile phase at a flow rate of 1.5 mL/min. The assay enables the measurement of clarithromycin for therapeutic drug monitoring with a minimum quantification limit of 20 ng/mL. The method involves simple, protein precipitation procedure and analytical recovery was complete. The calibration curve was linear over the concentration range of 0.1-6 μg/mL. The coefficients of variation for inter-day and intra-day assay were found to be less than 6%. This method was used in bioequivalency and pharmacokinetic studies of the test (generic) product 2 × 500 mg clarithromycin tablets, with respect to the reference product. PMID:24250673

  10. Bioequivalence of fixed-dose combinations of dapagliflozin and metformin with single-component tablets in healthy subjects and the effect of food on bioavailability.

    Science.gov (United States)

    de Bruin, Tjerk W A; Reele, Stots; Hamer-Maansson, Jennifer E; Parikh, Shamik; Tang, Weifeng

    2016-03-01

    The pharmacokinetics (PK) of dapagliflozin and metformin administered as fixed-dose combination (FDC) tablets (2.5 mg dapagliflozin/850 mg metformin or 5 mg dapagliflozin/1000 mg metformin) or as separate tablets in healthy subjects were evaluated in 2 separate studies. Study 1 evaluated PK by measuring mean ratios of area under the plasma concentration-time curve (time zero to infinity [AUCinf ]), AUC from zero to time of last measurable concentration (AUC0-t ), and maximum observed plasma concentration (Cmax ) for single-component or FDC tablets following a non-high-fat meal. Mean ratios of AUCinf , AUC0-t , and Cmax for FDC or single-component dapagliflozin and metformin tablets were close to unity. In study 2, AUCinf , AUC0-t , and Cmax for the FDC tablet were obtained fasting and after a high-fat meal. Dapagliflozin 5 mg and metformin 1000 mg geometric mean Cmax was increased in the fasted versus fed state (61.9 vs 43.9 and 1600 vs 1330 ng/mL, respectively), but AUC0-t was similar (267 and 265 and 11 000 and 10 600 ng · h/mL, respectively). In summary, FDC tablets were bioequivalent to single-component tablets, and total absorption (AUC) was similar for non-high-fat and high-fat meals. PMID:27138025

  11. 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

  12. 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...

  13. 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...

  14. 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.

  15. Paris convention - Decisions, recommendations, interpretations

    International Nuclear Information System (INIS)

    This booklet is published in a single edition in English and French. It contains decisions, recommendations and interpretations concerning the 1960 Paris Convention on Third Party Liability in the Field of Nuclear Energy adopted by the OECD Steering Committee and the OECD Council. All the instruments are set out according to the Article of the Convention to which they relate and explanatory notes are added where necessary

  16. 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...

  17. 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...

  18. Workers and the ICRP recommendations

    International Nuclear Information System (INIS)

    In both the preparation and the application of the recommendations presented by the ICRP one important voice has been absent: that of the workers in the nuclear industry. A large number of specialists are studying their situation from all points of view, in their different capacities as workers, consumers and male or female members of the public, but this extensive study is being done without consulting them, without their opinion even being asked for. The paper discusses such deficiencies, in particular all those aspects which distinguish these recommendations from a legal text. The lack of conciseness in the definition of the limit which the average annual dose to a large group of workers must not exceed (500 mrad) is considered. The possibility of a large number of workers being exposed for a long period is not acceptable if the decision is left to the manager of a nuclear facility alone. Cost-benefit analysis, as it is described in the ICRP text, cannot be considered to provide credible protection from the point of view of workers. Moreover, the various ICRP recommendations fail to mention such important matters as allowance for low-dose effects, disparities in the social security coverage offered to various categories of workers in the event of occupational illness, and the increasing use of migrant workers for difficult decontamination and maitenance tasks. At a time when it is thought that nuclear technology can be standardized, the French Democratic Labour Confederation (CFDT) expresses its fears concerning the practical application of the ICRP recommendations; for example, the text of ICRP Publication 26 has not yet been translated into French, but Euratom has already proposed directives for its application in Member States

  19. 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

  20. 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

  1. 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.

  2. 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.

  3. 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...

  4. 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...

  5. 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.

  6. Requirements Engineering for General Recommender Systems

    OpenAIRE

    Portugal, Ivens; Alencar, Paulo; Cowan, Donald

    2015-01-01

    In requirements engineering for recommender systems, software engineers must identify the data that drives the recommendations. This is a labor-intensive task, which is error-prone and expensive. One possible solution to this problem is the adoption of automatic recommender system development approach based on a general recommender framework. One step towards the creation of such a framework is to determine the type of data used in recommender systems. In this paper, a systematic review has b...

  7. 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

  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. Physical Exercise and MS Recommendations

    DEFF Research Database (Denmark)

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

    2009-01-01

    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...... 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...

  10. 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.

  11. 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.

  12. 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 .

  13. 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

  14. 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.

  15. 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

    Science.gov (United States)

    Luo, Zhu; Nan, Feng; Miao, Jia; Chen, Zhihui; Li, Mei; Liang, Maozhi

    2016-01-01

    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 properties in

  16. 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

  17. Assay of free captopril in human plasma as monobromobimane derivative, using RPLC/(+)ESI/MS/MS: validation aspects and bioequivalence evaluation.

    Science.gov (United States)

    Medvedovici, Andrei; Albu, Florin; Sora, Iuliana Daniela; Udrescu, Stefan; Galaon, Toma; David, Victor

    2009-10-01

    A sensitive method for determination of free captopril as monobromobimane derivative in plasma samples is discussed. The internal standard (IS) was 5-methoxy-1H-benzimidazole-2-thiol. Derivatization with monobromobimane immediately after blood collection and plasma preparation prevents oxidation of captopril to the corresponding disulfide compound and enhances the ionization yield. Consequently, derivatization enhances sample stability and detection sensitivity. Addition of the internal standard was made immediately after plasma preparation. The internal standard was also derivatized by monobromobimane, as it contains a thiol functional group. Preparation of plasma samples containing captopril and IS derivatives was based upon protein precipitation through addition of acetonitrile, in a volumetric ratio 1:2. The reversed-phase liquid chromatographic separation was achieved on a rapid resolution cartridge Zorbax SB-C(18), monitored through positive electrospray ionization and tandem MS detection using the multiple-reaction monitoring mode. Transitions were 408-362 amu for the captopril derivative and 371-260 amu for the internal standard derivative. The kinetics of captopril oxidation to the corresponding disulfide compound in plasma matrix was also studied using the proposed method. A linear log-log calibration was obtained over the concentration interval 2.5-750 ng/mL. A low limit of quantitation in the 2.5 ng/mL range was obtained. The analytical method was fully validated and successfully applied in a three-way, three-period, single-dose (50 mg), block-randomized bioequivalence study for two pharmaceutical formulations (captopril LPH 25 and 50 mg) against the comparator Capoten 50 mg. PMID:19402182

  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. Application of a UPLC-MS/MS method for the analysis of alosetron in human plasma to support a bioequivalence study in healthy males and females.

    Science.gov (United States)

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

    2015-10-01

    A simple, rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of alosetron (ALO) in human plasma. The assay method involved solid-phase extraction of ALO and ALO 13C-d3 as internal standard (IS) on a LichroSep DVB-HL (30 mg, 1 cm(3) ) cartridge. The chromatography was performed on an Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 µm) column using acetonitrile and 2.0 mm ammonium formate, pH 3.0 adjusted with 0.1% formic acid (80:20, v/v) as the mobile phase in an isocratic mode. For quantitative analysis, the multiple reaction monitoring transitions studied were m/z 295.1/201.0 for ALO and m/z 299.1/205.1 for IS in the positive ionization mode. The method was validated over a concentration range of 0.01-10.0 ng/mL for ALO. Post-column infusion experiment showed no positive or negative peaks in the elution range of the analyte and IS after injection of extracted blank plasma. The extent of ion-suppression/enhancement, expressed as IS-normalized matrix factor, varied from 0.96 to 1.04. The assay recovery was within 97-103% for ALO and IS. The method was successfully applied to support a bioequivalence study of 1.0 mg alosetron tablets in 28 healthy Indian male and female subjects. PMID:25761551

  20. IAEA recommendations on NPP safety

    International Nuclear Information System (INIS)

    Codes developed in IAEA on the basis of the NUSS program (Nuclear Safety Standards) concerning nuclear safety of thermal reactor NPPs and published in 1978 are considered. 5 main codes and manuals have been stated: 1. Governmental organization for the regulation of NPP; 2. Safety in NPP siting; 3. Design for safety of NPP; 4. Safety in NPP operation; 5. Quality assuarance for safety in Nuclear Power Plants. The Codes contain recommendations on providing safety of population and personnel as well as on environmental protection. They also contain criteria and proper measures corresponding to both operating conditions of NPP and possible emergency conditions. Some provisions in the Codes may be also used, for providing radiation safety and at the external fuel cycle plants

  1. 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

  2. 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

  3. 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...

  4. 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 ...

  5. Context Similarity Metric for Multidimensional Service Recommendation

    OpenAIRE

    Liwei Liu, Nikolay Mehandjiev, and Dong-Ling Xu

    2013-01-01

    Recommender systems support online customers by suggesting products and services of likely interest to them. Considering the customer context is believed to produce better recommendations, yet it poses unique challenges. If recommendation is generated through previous ratings, narrowing down the set of ratings to those under the target context will limit their number producing poor quality recommendations. A common approach to improve the quality is to aggregate ratings from a number of simil...

  6. 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...

  7. 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.

  8. Recommendable Practices for Effective Nuclear Crisis Communication

    International Nuclear Information System (INIS)

    'Crisis communication' refers one of the activities done by the Nuclear Regulatory Organizations (NROs) in order to protect the public and the environment from the possible harmful effects. As denoted by the BMU, German NRO, crisis communication is not only 'public information' or 'information for the public', but also communication between authorities in order to guarantee that public information is consistent. This study proposes some recommendable practices for developing a guideline of well-prepared nuclear crisis communication system, including its management framework, and for introducing good insights, based on the study of international aspects provided by relevant OECD/NEA WPGC (Working Group on Public Communication for Nuclear Regulatory Organizations)i working group

  9. Environmental Issues in Jordan, Solutions and Recommendations

    Directory of Open Access Journals (Sweden)

    Nidal A.   Hadadin

    2007-01-01

    Full Text Available Jordan’s natural resources are limited to support population in a sustainable manner. However, its environment is exposed to a number of threats. In order to best explain Jordan's environmental difficulties, it would be prudent to focus individually on each of these major concerns: water shortages, agriculture/land and air pollution. This study focuses on the environmental problems in Jordan and has addressed the process of reversing environmental decline. A true foundation of environmental protection requires awareness upon the part of the population and a number of governmental and non-governmental organizations are actively involved in educating the populace about environmental issues. This article presents specific recommendations addressing water resources, the areas of agriculture and air pollution. It emphasis throughout on the conservation of water, agriculturally productive land and the quality of air, of which, the contamination or loss of them would bring rapid and significant consequences to Jordan.

  10. 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

  11. 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.

  12. 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。

  13. 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.

  14. Fusing Recommendations for Social Bookmarking Websites

    DEFF Research Database (Denmark)

    Bogers, Toine; van den Bosch, Antal

    2011-01-01

    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...... find that fusing recommendations can indeed produce significant improvements in recommendation accuracy. We also find that it is often better to combine approaches that use different data representations, such as tags and metadata, than to combine approaches that only vary in the algorithms they use...

  15. 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.

  16. Erotomania and Recommendations for Treatment.

    Science.gov (United States)

    Seeman, Mary V

    2016-06-01

    The aim of this paper is to help clinicians better understand how erotomania originates in order to facilitate treatment and make it more effective. Data sources are the narratives of six women who spoke in detail about the beginnings of their delusional beliefs and about the nature of the evidence that convinced them that their beliefs were well-founded. In every case, low self-esteem and emotional arousal preceded the emergence of the delusion. Misperceptions and misattributions appeared responsible for keeping the delusion alive. Despite external disconfirmation, social isolation protected the delusional beliefs from revision and extinction. The erotomanic delusion provided a sense of well-being that probably contributed to its maintenance. As well, a delusion-induced boost in well-being delayed help-seeking. Recommendations for treatment include staged interventions, first establishing a therapeutic alliance with a focus on understanding the psychological factors contributing to the origin and maintenance of the delusion. The next stage is the provision of social support and strategies directed at the restoration of self-esteem. The third stage is the gradual introduction of techniques to correct cognitive biases. Medication and risk management form an integral part of overall management. Objective evidence for the effectiveness of this approach is, however, not yet available. PMID:26442945

  17. 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

  18. 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

  19. 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.

  20. Persuasive Recommender Systems Conceptual Background and Implications

    CERN Document Server

    Yoo, Kyung-Hyan; Zanker, Markus

    2013-01-01

    Whether users are likely to accept the recommendations provided by a recommender system is of utmost importance to system designers and the marketers who implement them. By conceptualizing the advice seeking and giving relationship as a fundamentally social process, important avenues for understanding the persuasiveness of recommender systems open up. Specifically, research regarding influential factors in advice seeking relationships, which is abundant in the context of human-human relationships, can provide an important framework for identifying potential influence factors in recommender system context. This book reviews the existing literature on the factors in advice seeking relationships in the context of human-human, human-computer, and human-recommender system interactions. It concludes that many social cues that have been identified as influential in other contexts have yet to be implemented and tested with respect to recommender systems. Implications for recommender system research and design are dis...

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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....

  6. 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.

  7. 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.

  8. Recommendation System Based on Fuzzy Cognitive Map

    Directory of Open Access Journals (Sweden)

    Wei Liu

    2014-07-01

    Full Text Available With the increase of data volume and visitor volume, the website faces great challenge in the environment of network. How to know the users’ requirements rapidly and effectively and recommend the required information to the user becomes the research direction of all websites. The researchers of recommendation system propose a series of recommendation system models and algorithms for the user. The common challenge faced by these algorithms is how to judge the user intention and recommend the relevant content by little user action. The paper proposes the user situation awareness and information recommendation system based on fuzzy clustering analysis and fuzzy cognitive maps, and verifies the validity of the algorithm by the application to recommendation site of academic thesis.

  9. 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.

  10. 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...

  11. 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

  12. A Personalized Tag-Based Recommendation in Social Web Systems

    DEFF Research Database (Denmark)

    Durao, Frederico; Dolog, Peter

    2009-01-01

    Tagging activity has been recently identified as a potential source of knowledge about personal interests, preferences, goals, and other attributes known from user models. Tags themselves can be therefore used for finding personalized recommendations of items. In this paper, we present a tag......-based recommender system which suggests similar Web pages based on the similarity of their tags from a Web 2.0 tagging application. The proposed approach extends the basic similarity calculus with external factors such as tag popularity, tag representativeness and the affinity between user and tag. In order to...

  13. Making Personalised Flight Recommendations using Implicit Feedback

    OpenAIRE

    Coyle, Lorcan

    2004-01-01

    As e-commerce has become more popular, the problem of information overload has come to the fore. Recommender systems that reduce the information overload problem are becoming more common. However, the problem with many recommender systems is that they are associated with a high cost of learning customer preferences (in terms of cognitive load). We describe the Personal Travel Assistant (PTA), a flight recommender application that uses case-based reasoning (CBR) to overcome these problem...

  14. An Agent Framework of Tourism Recommender System

    OpenAIRE

    Jia Zhi Yang; Gao Wei; Shi Yi Jin

    2016-01-01

    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 Ag...

  15. Evaluating Information Presentation Strategies for Spoken Recommendations

    OpenAIRE

    Winterboer, Andi; Moore, Johanna D.

    2007-01-01

    We report the results of a Wizard-of-Oz (WoZ) study comparing two approaches to presenting information in a spoken dialogue system generating flight recommendations. We found that recommendations presented using the user-model based summarize and refine (UMSR) approach enable more efficient information retrieval than the data-driven summarize and refine (SR) approach. In addition, user ratings on four evaluation criteria showed a clear preference for recommendations based on the UMSR approach.

  16. Web Page Recommendation Using Web Mining

    OpenAIRE

    Modraj Bhavsar; Mrs. P. M. Chavan

    2014-01-01

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

  17. From Word Embeddings to Item Recommendation

    OpenAIRE

    Ozsoy, Makbule Gulcin

    2016-01-01

    Social network platforms can archive data produced by their users. Then, the archived data is used to provide better services to the users. One of the services that these platforms provide is the recommendation service. Recommendation systems can predict the future preferences of users using various different techniques. One of the most popular technique for recommendation is matrix-factorization, which uses low-rank approximation of input data. Similarly, word embedding methods from natural ...

  18. Group Recommender System for Restaurant Lunches

    OpenAIRE

    Hallström, Erik

    2013-01-01

    A group recommender system for lunch restaurants is developed. The user interface is an Android application which is run on a smartphone. The system features a novel approach for implicit rating collection when a user browses a list of item descriptions. The individual recommendation is based on extracting and comparing tf-idf feature vectors of menu texts as well as individual rankings of the restaurants. The group recommender system works by aggregating the individual estimated scores of th...

  19. 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.

  20. 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