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Sample records for bioequivalence study electronic

  1. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

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

    2007-01-01

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

  2. Organizational aspects of conducting of bioequivalence study

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    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.

  3. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ...] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted... guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted... draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

  4. The importance of bioequivalence study: focus on clopidogrel

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    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

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

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

    2016-09-01

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

  6. A limited sampling approach in bioequivalence studies: application to long half-life drugs and replicate design studies.

    Science.gov (United States)

    Mahmood, I; Mahayni, H

    1999-06-01

    The objectives of this study was to develop a limited sampling model (LSM) to predict the area under the curve (AUC) and the maximum plasma concentration (Cmax) for the assessment of bioequivalence studies. Two drugs (A and B) were selected for this purpose. Drug A was chosen to test bioequivalence of two formulations with a long half-life (> 35 hours), whereas drug B was chosen to test the bioequivalence of two formulations (half-life = 12 hrs) with a replicate design study. The LSM for both drugs was developed using 5 blood samples each from 15 healthy subjects. The relationship between plasma concentration (independent variable) at selected time points with the AUC or Cmax (dependent variable) was evaluated by multiple linear regression analysis. The multiple linear regression which gave the best correlation coefficient (r) for 5 sampling time vs AUC or Cmax was chosen as the LSM. The predicted AUC and Cmax from the LSM were then used to assess bioequivalence of two different formulations of each drug following a single oral dose. The model provided good estimates of both AUC and Cmax for both drugs. The 90% confidence intervals on log-transformed observed and predicted AUC and Cmax were comparable for both drugs. The method described here may be used to estimate AUC and Cmax for bioequivalence studies for drugs with long half-lives or for highly variable drugs which may require replicate design studies without detailed blood sampling.

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

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    Manuel Ibarra

    2016-06-01

    Full Text Available 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].

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

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    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

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

  9. In vitro bioequivalence study of nine brands of artesunate tablets marketed in Nigeria.

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    Esimone, C O; Okoye, F B C; Onah, B U; Nworu, C S; Omeje, E O

    2008-03-01

    The availability of numerous brands of artesunate in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to predict the bioequivalence of nine brands of artesunate tablets marketed in Nigeria using in vitro tests. The in vitro dissolution study was carried out on the nine brands of artesunate tablets using the basket method according to US Pharmacopoeia (USP) guidelines. Other general quality assessment tests like hardness and disintegration time were also determined. All the brands tested passed the British Pharmacopoeia (BP) standard for disintegration time. Only AT2, AT4, AT6 and AT9 passed the standard for hardness. There were significant differences in the dissolution profiles of the nine brands. All the brands except AT1, however, released >70% of artesunate within 30 min. Four of the brands AT5, AT6, AT7 and AT8 exhibited >90% dissolution in AT9 (innovator brand) have calculated similarity factors of 23.8, 59.8, 50, 54.8 and 100. Based on the in vitro tests, AT5, AT6, AT7 and AT8 are considered bioequivalent and interchangeable, while AT2, AT3 and AT4 are considered bioequivalent and interchangeable with the innovator brand (AT9). AT1 has very low dissolution rate, which will likely result in poor bioavailability. The results show the need for constant monitoring of new brands of artesunate introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards.

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

    Science.gov (United States)

    Kamdi, Sandesh P.; Palkar, Prashant J.

    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 by high-performance liquid chromatography with UV detection. Pharmacokinetic parameters were analyzed based on noncompartmental analysis. The logarithmically transformed data of AUC0−∞ and C max were analyzed for 90% confidence intervals (CI) using ANOVA. The mean (90% CI) values for the ratio of AUC0−∞ and C max values of the test product over those of the reference product were 90.21 (83.69–97.24) and 108.68 (100.21–117.86), respectively (within the bioequivalence range of 80–125%). On the basis of pharmacokinetic parameters including AUC0−∞, AUC0−t, and C max values, both the formulations were bioequivalent. PMID:23476803

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

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    Tjandrawinata RR

    2013-08-01

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

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

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

    2014-05-01

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

  13. L-T4 bioequivalence and hormone replacement studies via feedback control simulations.

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    Eisenberg, Marisa; Samuels, Mary; DiStefano, Joseph J

    2006-12-01

    FDA Guidance for testing bioequivalence of levothyroxine (L-T(4)) preparations has been challenged by several groups, based on multiple issues. The efficacy of single versus combined hormone therapy also is receiving additional scrutiny. To examine these concerns, we developed a new nonlinear feedback system simulation model of whole-body regulation mechanisms involving dynamics of T(3), T(4), TSH, plasma protein binding, extravascular regulatory enzyme systems, and the hypothalamic-pituitary-thyroid axis, all quantified from human data. To address bioequivalence, we explored how to best account for varying and unmeasured endogenous T(4) following dosing with exogenous oral L-T(4) in euthyroid volunteers in required pharmacokinetic (PK) studies, by simulating various dosing scenarios and developing a new and simple correction method. We computed and assessed dosing error effects and baseline corrections using simulator-predicted endogenous T(4) level variations, due to actual closed-loop effects, and compared these with approximate corrections computed directly from PK data. Predicted dose-responses were quite linear, and for constant baseline, 7-day half-life, and our new formula-correction methods, we established some bounds on bioequivalent dosages. Simulated replacement after thyroidectomy required 141 microg L-T(4) only to normalize T(3) tissue levels and 162 microg L-T(4) to normalize plasma T(3) levels. A combined dose of approximately 103 microg L-T(4) plus approximately 6 microg T(3) ( approximately 18:1 ratio) was needed to normalize both plasma T(3) and T(4) and average tissue T(3) levels. However, simulated average tissue T(3) levels were normalized with standard L-T(4)-only therapy, and plasma T(3) levels were still within the normal range. We suggest a simple and more accurate correction for endogenous T(4) in PK studies. Current standard L-T(4)-only treatment is supported for routine replacement needs.

  14. Sensitivity of empirical metrics of rate of absorption in bioequivalence studies.

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    Ring, A; Tothfalusi, L; Endrenyi, L; Weiss, M

    2000-05-01

    The sensitivity and effectiveness of indirect metrics proposed for the assessment of comparative absorption rates in bioequivalence studies [Cmax, Tmax, partial AUC (AUCp), feathered slope (SLf), intercept metric (I)] were originally tested by assuming first-order absorption. The present study re-evaluates their sensitivity performances using the more realistic inverse Gaussian (IG) model characterizing the input process for oral drug administration. Simulations were performed for both the first-order or exponential model (EX) which is determined by only one parameter, the mean absorption time (MAT = 1/k(a)), and the IG model, which additionally contains a shape parameter, the relative dispersion of absorption time distribution (CV2A). Kinetic sensitivities (KS) of the indirect metrics were evaluated from bioequivalence trials (error free data) generated with various ratios of the true parameters (MAT and CV2A) of the two formulations. The behavior of the metrics was similar with respect to changes in MAT ratios with both models: KS was low with Cmax, moderate with SLf and AUCp, and high with I and Tmax following correction for apparent lag time (Tlag). Changes of the shape parameter CV2A, however, were not detectable by Cmax, Tmax, SLf, and AUCp. Changes in both MAT and CV2A were well reflected by I with CV2A - ratio > 1. I exhibited approximately full KS also with CV2A - ratio correction was first applied for the apparent lag time. The time profile of absorption rates is insufficiently characterized by only one parameter (MAT). Indirect metrics which are sensitive enough to detect changes in the scale and shape of the input profile could be useful for bioequivalence testing. Among the tested measures, I is particularly promising when a correction is applied for Tlag.

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

    Science.gov (United States)

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

    2017-09-01

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

  16. Bioequivalence study of two enteric coated capsule formulations of ...

    African Journals Online (AJOL)

    Medical profession has realized the problem of wide variations in the therapeutic effectiveness of various brands of oral formulations containing the same active ingredient in equal amounts. The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence single-dose crossover ...

  17. Pharmacogenetic relevance of the CYP2C9*3 allele in a tenoxicam bioequivalence study performed on Spaniards.

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    Peiró, A M; Novalbos, J; Zapater, P; Moreu, R; López-Rodríguez, R; Rodríguez, V; Abad-Santos, F; Horga, J F

    2009-01-01

    We performed a study to quantify CYP2C9 and CYP2C8 alleles influence on the variability observed in tenoxicam pharmacokinetic (PK) and implication in a bioequivalence study design performed on Spaniards. Eighteen healthy volunteers were included in an open, randomized, crossover, phase I bioequivalence study. Significant increases were found in CYP2C9*3 alleles vs. *1 and *2 in AUC(0-infinity) (median (min-max)): 256 (230-516) vs. 150 (100-268) and 169 (124-197) microg h/mL (p<0.01) and half-life time (t1/2) 102 (79-36) vs. 56 (45-94) and 64 (60-80)h (p<0.01). Non-significant differences were observed in C(max) 1.9 (1.8-2.9) vs. 2.4 (1.7-3.4), 2.5 (1.6-2.9) microg/mL or in according to CYP2C8 alleles presence. CYP2C9*3 allele is associated to a longer elimination time of tenoxicam. PK parameters calculated in bioequivalence studies (AUC(0-infinity), t1/2) may be influenced by the presence of CYP2C9*3 allele resulting in a high variability. Thus, bioequivalence studies of tenoxicam formulations should be designed considering genotype profile.

  18. Pharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteers.

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    Tian, Yuan; Zhang, Jing-Jing; Feng, Shu-Dan; Zhang, Zun-Jian; Chen, Yun

    2008-01-01

    The pharmacokinetics of aniracetam (CAS 72432-10-1) in Chinese healthy male volunteers was investigated for the first time. Twenty male volunteers were enrolled into this open, randomized, single blind two-sequence, two-period crossover study. Under fasting conditions, each subject received a single oral dose of 400 mg (2 x 200 mg/capsule) aniracetam as a test or reference formulation with a 3-day washout period between the two preparations. The plasma concentrations of aniracetam were analyzed by a sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The pharmacokinetic parameters of the test and reference formulations were estimated as follows: The maximum plasma concentrations (Cmax) were 8.75 +/- 7.82 and 8.65 +/- 8.70 ng/mL, Tmax were 0.4 +/- 0.1 and 0.4 +/- 0.1 h, and plasma elimination half-lives (t(1/2)) were 0.47 +/- 0.16 and 0.49 +/- 0.24 h, respectively. The AUC(0-t) values demonstrated nearly identical bioavailability of aniracetam from the examined formulations. AUC(0-2.5) values were 4.53 +/- 6.62 and 4.76 +/- 6.65 ng h/mL, the areas under the plasma concentration-time curve (AUC(0-infinity) were 4.62 +/- 6.66 and 4.85 +/- 6.71 ng h/mL for the test and reference formulation, respectively. No statistical differences were observed for Cmax, and AUC(0-infinity) for aniracetam. The 90% confidence limits calculated for AUC and Cmax of aniracetam were within the standard bioequivalence range (80%-125% for AUC and Cmax). Therefore, the aniracetam test formulation can be regarded as bioequivalent to the aniracetam reference formulation.

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

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    K. O. Zupanets

    2016-03-01

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

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

    Science.gov (United States)

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

    2010-12-01

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

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

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    Werawath Mahatthanatrakul

    2008-05-01

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

  2. Bioequivalence study of two enalapril maleate tablet formulations in healthy male volunteers. Pharmacokinetic versus pharmacodynamic approach.

    Science.gov (United States)

    Ribeiro, W; Muscará, M N; Martins, A R; Moreno, H; Mendes, G B; de Nucci, G

    1996-01-01

    Two different conventional release enalapril maleate tablet formulations were evaluated for their relative bioavailability (Eupressin tablets 10 mg, Biosintética as the test formulation vs Renitec tablets 10 mg Merck Sharp & Dhome, as the reference formulation). A single 20 mg oral dose of each preparation was administered to 18 healthy male adult volunteers and their bioequivalence was assessed by comparing the serum enalaprilat and total enalapril (enalaprilat plus enalapril maleate) concentration-time curves. Angiotensin converting enzyme (ACE) activity was also quantified in each serum sample. The pharmacokinetic parameters obtained for each formation were the area under the time-concentration curve from 0 to 24 h (AUC[0-24]), maximum concentration Cmax and the time at which it occurred (tmax). When serum enalaprilat concentration-time curves were employed to assess bioequivalence, the formulations were bioequivalent in the extent but not in the rate of absorption. However, no difference in either the extent or the rate of absorption were observed when serum total enalapril vs time curves were analysed. ACE activity-time curves were similar for both formulations and showed that ACE was 90% inhibited for 3-5 h after enalapril administration, and till approximately 50% after 24 h. At that time, circulating enalaprilat and total enalapril levels were less than the tenth of Cmax. The results show that complete bioequivalence of the two formulations can be concluded from serum total enalapril concentration data, and that serum ACE activity is not a suitable pharmacodynamic variable for assessing bioequivalence.

  3. Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate.

    Science.gov (United States)

    Lopes, Renato Almeida; Neves, Francisco de Assis Rocha

    2010-01-01

    The generic drugs program provided a better population's access to medicines. To ensure interchangeability between a brand-name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequivalence. To evaluate the safety interchangeability between different generic and similar drugs with Hydrochlorothiazide and Enalapril Maleate, a meta-analysis was carried out with several bioequivalence studies with these drugs. Data from bioequivalence of generic and similar drugs approved by the National Health Surveillance Agency (Anvisa) (drug regulatory agency in Brazil) were used. The compatibility of data from each study was analyzed and the determination of a confidence interval for the differences between the means of pharmacokinetic parameters, area under the curve (ASC0-t) and maximum plasma concentration (Cmax), was made for each study by meta-analysis. The interchangeability between the combinations of the three products with Hydrochlorothiazide was confirmed based on the obtained confidence intervals. For the drugs studied with Enalapril Maleate interchangeability has not been confirmed for 50% of the product comparisons. The exchange was established between the three products with hydrochlorothiazide. However, for the Enalapril Maleate half of the products studied are not interchangeable, considering they do not match the established intervals for bioequivalence tests, so the pharmacokinetics behavior and thus the effectiveness of the product may be changed.

  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.

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

    Science.gov (United States)

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

    2017-02-01

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

    Science.gov (United States)

    Huang, J; Chen, R; Li, R; Wei, C-M; Yuan, G-Y; Liu, X-Y; Wang, B-J; Guo, R-C

    2012-01-01

    To assess the bioequivalence of a new generic formulation of misoprostol (CAS 59122-46-2) 0.2 mg tablets (test) and the available branded tablet (reference) for the requirement of state regulatory criteria and the marketing of the test product in China. A randomized-sequence, 2-period crossover study was conducted in 20 healthy Chinese female volunteers in the fasted state. Blood samples were collected at baseline and 0.083, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 and 6 h after a single oral dose of 0.6 mg misoprostol test or reference, followed by a 7-day washout period. Misoprostol acid, the active metabolite of misoprostol, was determined by an HPLC-MS/MS method. Drug And Statistics 2.0 was used to calculate the pharmacokinetics parameters and assess bioequivalence of the 2 formulations. It was considered bioequivalent if the 90% CIs of the mean ratios (test: reference) for Tmax, Cmax and AUC0-t were all within the range from 80% to 125%. Adverse events were monitored throughout the study based on clinical parameters and patient reports. The main pharmacokinetics parameters for the test and reference were as follows: t1/2 was (0.680 ± 0.371) h and (0.650 ± 0.264) h; Tmax was (0.415 ± 0.087) h and (0.399 ± 0.097) h; Cmax was (1.941 ± 0.417) ng/mL and (2.047 ± 0.397) ng/mL; AUC0-t was (1.535 ± 0.419) ng·h/mL and (1.652 ± 0.400)ng·h/mL, and the AUC0-∞ was (1.576 ± 0.465) ng·h/mL and (1.686 ± 0.396) ng·h/mL. The mean ratios (test: reference) for Cmax, AUC0-t, and AUC0-∞ were 95.3% ±13.2%, 92.65% ± 17.31%, and 93.61%±18.97%, respectively. No significant (p>0.05) differences in pharmacokinetic parameters were found between preparations, treatments and periods. This single-dose study in healthy Chinese fasted volunteers was shown that the misoprostol test and reference met the requirement of US and China regulatory criterion, and the test and reference were bioequivalent. © Georg Thieme Verlag KG Stuttgart · New York.

  7. 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 

  8. A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies.

    Science.gov (United States)

    Cristofoletti, Rodrigo; Chiann, Chang; Dressman, Jennifer B; Storpirtis, Silvia

    2013-09-01

    Although policies of waiving bioequivalence studies are part of the legal framework of various regulatory agencies, there is no harmonization with regard to extension of the biowaiver to drugs other than those with high solubility and high permeability, nor is there any consensus or official endorsement of the biopharmaceutics drug disposition classification system (BDDCS). To better understand the applicability of the biowaiver, we carried out a cross-sectional survey to estimate the relative risk of obtaining nonbioequivalent (non-BE) or bioinequivalent (BIE) results for drug products containing drugs belonging to each of the biopharmaceutics classification system (BCS) and BDDCS classes. Five hundred bioequivalence studies were randomly sampled from a database of the Brazilian Health Surveillance Agency (ANVISA). The drugs were classified according to the BCS and BDDCS, to evaluate how characteristics related to drug and dosage form influence the outcome of bioequivalence studies. The relative risk of obtaining a non-BE result was approximately four times lower for drugs in classes 1 and 3 of BCS or BDDCS when compared with class 2 drugs. Thus, it seems that the final outcome of a bioequivalence study is strongly influenced by the solubility of the drug, but not by its intestinal permeability or extent of metabolism. Copyright © 2013 Wiley Periodicals, Inc.

  9. 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.

  10. 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.

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

    Science.gov (United States)

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

    2017-04-01

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

    Science.gov (United States)

    Tothfalusi, L; Endrenyi, L

    2001-04-01

    One of the claimed benefits of the individual bioequivalence (IBE) approach has been that the aggregate regulatory model rewards a test formulation when it has a within-subject variation smaller than the reference product. Hauck et al. [1996] demonstrated that, in the absence of random variations, this property of IBE was due to the tradeoff between the difference of the means and the deviation between the intrasubject variances of the two formulations. The tradeoff was a consequence of the aggregate regulatory model. However, calculations of Endrenyi and Hao [1998] showed that, in the presence of random variations, not only rewards but also penalties can arise due to chance alone. A data set of 55 investigations made public by the FDA in 1999 and containing replicate crossover designs was analyzed. Two parameters, AUC and Cmax, were determined in each investigation. The analyses of the FDA data indicate that: rewards and penalties occur at similar frequencies, large rewards and penalties are recorded quite often, and the aggregate IBE model is rather insensitive to the difference between the estimated means and is compatible with the frequent occurrence of large deviations. Rewards and penalties, apparently arising from random variations, can affect regulatory decisions on the acceptance of IBE and can lead to incorrect conclusions.

  13. Bioequivalence study of four different trademarks of enalapril maleate in spontaneously hypertensive rats.

    Science.gov (United States)

    Baracho, Nilo César do Vale; Arruda, Guilherme D'Andréa Saba; Alves, Lidinei José; Carneiro, Márcio Felipe Salomon; Siqueira, Matheus Teodoro Grilo; Arango, Héctor Gustavo; Marcos dos Reis, José

    2008-01-01

    High blood pressure is a systemic disease which has major clinical and psycho-social repercussions, involves a high morbidity-mortality rate and generates high costs for the health system. Its treatment involves the use of antihypertensive drugs, which are commercialized as trademark, generic or similar drugs. To verify the antihypertensive effect produced by a similar dose of different trademarks of enalapril maleate in spontaneously hypertensive rats (SHR). Fifteen mg/kg of enalapril maleate were administered by gavage in 50 SHR rats and their blood pressure was verified through tail plethysmography every three days in a period of 16 days. The group treated with reference drug has shown a significant reduction on blood pressure levels when compared to the control group. Thus, treatments with enalapril maleate of generic, similar-A and similar-B brands have also shown significant reduction on animals' blood pressure. The use of generic drug and similars (A and B) drugs in the same doses and for the same period of time has not shown significant difference regarding the reference drug, which suggests that the brands tested are bioequivalent.

  14. A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults.

    Science.gov (United States)

    Sikes, Carolyn; Stark, Jeffrey G; McMahen, Russ; Engelking, Dorothy

    2017-11-01

    The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®. In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for d- and l-amphetamine concentrations, and pharmacokinetic parameters C max , AUC 0-5 , AUC 5-last , and AUC inf were calculated to determine bioequivalence. Safety was monitored throughout the study. The 90% confidence intervals (CIs) for the log-transformed C max , AUC 0-5 , AUC 5-last , and AUC inf fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine. The most common adverse events were nausea and decreased appetite. AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.

  15. Bioequivalence study of two formulations of flupirtine maleate capsules in healthy male Chinese volunteers under fasting and fed conditions

    Directory of Open Access Journals (Sweden)

    Liu YF

    2017-12-01

    Full Text Available Yanfang Liu, Hua Huo, Zhibo Zhao, Wenli Hu, Yujia Sun, Yunbiao Tang Technical Center for Clinical Pharmacy, Department of Drug Clinical Trail Management Agency, General Hospital of Shenyang Military Area Command, Shenyang, China Aim: This study developed a high-performance liquid chromatography–tandem mass spectrometry method to simultaneously determine the concentrations of flupirtine and its major active metabolite D-13223 in human plasma in order to assess the bioequivalence (BE of two flupirtine maleate capsules among healthy male Chinese volunteers under fasting and fed conditions. Materials and methods: There were two single-center, randomized, single-dose, open-label, laboratory-blinded, two-period, cross-over studies which included 24 healthy male Chinese volunteers under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 48 h after dosing. The concentrations of flupirtine and its major active metabolite D-13223 in plasma samples were determined by a validated method, that is, high-performance liquid chromatography coupled with a tandem mass spectrometry detector. Pharmacokinetic metrics of area from time zero to the last measurable concentration (AUC0-t, area under the plasma concentration–time curve from administration to infinite time (AUC0-∞, and Cmax were used for BE assessment. Results: Forty-eight healthy volunteers who met the criteria were enrolled and completed the study. According to the observation of vital signs and laboratory measurement, no volunteers had any adverse reactions. Under fasting condition, the geometric mean ratios (90% CI of the test/reference drug for flupirtine were 103.0% (98.1%–108.2% for AUC0-t, 102.9% (98.2%–107.9% for AUC0-∞, and 97.0% (85.9%–109.5% for Cmax. Under fed condition, the geometric mean ratios (90% CI of the test/reference drug for flupirtine were 101.7% (98.4%–105.1% for AUC0-t, 101.6% (98.5%–104.8% for AUC0-∞, and 103.5% (94.7%

  16. 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.

  17. 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%.

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

    Science.gov (United States)

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

    2013-11-01

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

  19. Bioequivalence of lamotrigine 50-mg tablets in healthy male volunteers: a randomized, single-dose, 2-period, 2-sequence crossover study.

    Science.gov (United States)

    Perez-Lloret, S; Olmos, L; de Mena, F; Pieczanski, P; Rodriguez Moncalvo, J J

    2012-10-01

    OBEJCTIVE: To compare the bioavailability of two 50-mg lamotrigine dispersible tablet formulations (Epilepax®, Ivax-TEVA Argentina Laboratories, Argentina, as a test formulation, and Lamictal®, GlaxoSmithKline, UK, as a reference formulation) in 24 healthy male volunteers. This study was a randomized, 2-period, 2-sequence crossover design that was open for subjects and investigators, but blind for the bioanalytical lab. Serum samples were obtained over a 120-h interval. A 9-day wash-out period was allowed between treatments. The concentrations of lamotrigine were analyzed by high-performance liquid chromatography followed by ultraviolet-visible detection. Lamotrigine time-concentrations curves were obtained and the following pharmacokinetic parameters were calculated: AUC0-t, AUC0-inf and Cmax. Bioequivalence was declared if the 90% confidence interval (CI) of the mean test/reference ratios for AUC0-t, AUC0-inf and Cmax were within 80.00-125.00%. The geometric mean and respective 90% CI of test/reference percent ratios were 100.83% (92.53-107.88%) for AUC0-t, 99.91% (93.79-108.40%) for AUC0-inf, and 95.62% (90.91-100.57%) for Cmax. No serious adverse events were observed. 1 patient reported a mild rash following the administration of each formulation. This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in this sample of fasting healthy volunteers. These results suggest that bioequivalence studies evaluating 50-mg doses of Lamotrigine are feasible and recommended, since such doses may minimize the risk of severe rash or Stevens-Johnson Syndrome. This study was registered at the Argentinean Clinical Trials National Registry (www.anmat.gov.ar), No 1666/2008. © Georg Thieme Verlag KG Stuttgart · New York.

  20. 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.

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

    Science.gov (United States)

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

    2009-11-01

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

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

    Directory of Open Access Journals (Sweden)

    2000-03-01

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

  3. Pharmacokinetic properties and bioequivalence of two sulfadoxine/pyrimethamine fixed-dose combination tablets: a parallel-design study in healthy Chinese male volunteers.

    Science.gov (United States)

    Liu, Yan-Mei; Zhang, Kanyin E; Liu, Yun; Zhang, Hai-Chen; Song, Yun-Xiao; Pu, Hua-Hua; Lu, Chuan; Liu, Gang-Yi; Jia, Jing-Ying; Zheng, Qing-Si; Zhu, Jian-Min; Yu, Chen

    2012-11-01

    Sulfadoxine/pyrimethamine fixed-dose combination (FDC) tablet is the long-acting portion of the antimalaria product Artecospe(®), coblister containing artesunate tablets plus sulfadoxine/pyrimethamine FDC tablets. This study was conducted to support the efficacy and tolerability of the sulfadoxine/pyrimethamine FDC tablet in the World Health Organization's (WHO) Prequalification of Medicines Programme, as well as to obtain marketing authorization in China. The aim of the present study was to compare the pharmacokinetic profiles between a new generic and the branded reference formulation of sulfadoxine/pyrimethamine FDC tablets, and to assess the bioequivalence of the 2 products in healthy Chinese volunteers. This single-dose, open-label, randomized, parallel-group study was conducted in healthy Chinese male volunteers who were randomly assigned (1:1) to receive a single 1500/75-mg dose (3 × 500/25-mg tablets) of either the test or reference formulation after a 12-hour overnight fast. Seventeen blood samples were obtained over a 168-hour interval, and plasma concentrations of sulfadoxine and pyrimethamine were determined by 2 separate validated liquid chromatography-isotopic dilution mass spectrometry methods. Pharmacokinetic properties (C(max), AUC(0-72), AUC(0-168), and T(max)) were calculated and analyzed statistically. The 2 formulations were to be considered bioequivalent if 90% CIs for the log-transformed ratios of C(max) and AUC(0-72) were within the predetermined bioequivalence range of 80% to 125%, in accordance with the guidelines of WHO and China's Food and Drug Administration (FDA). Tolerability was evaluated throughout the study by vital signs, physical examinations, clinical laboratory tests, 12-lead ECGs, and subject interviews on adverse events (AEs). Forty-six healthy subjects completed the study. The mean values of sulfadoxine C(max) (183.07 and 165.15 mg/L), AUC(0-72) (11,036.52 and 10,536.78 mg/L/h), and AUC(0-168) (22,247.05 and 21,761.02 mg

  4. Comparative assessment of saliva and plasma for drug bioavailability and bioequivalence studies in humans

    Directory of Open Access Journals (Sweden)

    Nasir M. Idkaidek

    2017-07-01

    Conclusion: Our results suggest that there is a potential in BA/BE studies for saliva to be considered as a surrogate for plasma concentration, which goes along with drug regulations. The use of saliva instead of plasma in such studies makes them non-invasive, easy and with a lower clinical burden.

  5. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study.

    Science.gov (United States)

    Schnabel, Peter; Merki-Feld, Gabriele S; Malvy, Alice; Duijkers, Ingrid; Mommers, Ellen; van den Heuvel, Michiel W

    2012-06-01

    The etonogestrel (ENG)-releasing implant is a subdermal progestogen-only contraceptive that provides coverage for up to 3 years. This long-acting hormonal contraceptive has been available in Europe since 1998 and in the US since 2006. To date, localization of non-palpable implants at insertion and before removal has been dependent on ultrasound or magnetic resonance imaging by an experienced clinician. To facilitate localization in rare cases of non-palpable implants using widely available equipment without the need for a specialist, a radiopaque ENG implant has been developed that is detectable by two-dimensional x-ray imaging. This study aimed to establish whether the radiopaque ENG implant is bioequivalent in situ compared with the original non-radiopaque ENG implant, and to assess x-ray visibility of the radiopaque ENG implant. This was a 3-year, randomized, double-blind, parallel-group study carried out in nine international clinical trial centres. Women aged 18-40 years at the time of screening, with menstrual cycles of a usual length of 24-35 days and a body mass index of between ≥18 and ≤29 kg/m(2) were included. Women were assigned to either the radiopaque or non-radiopaque ENG implant in a 1 : 1 ratio via a block randomization by centre. Bioequivalence testing was performed based on the peak ENG concentration (C(max)), and the area under the curve (AUC) for ENG at 6, 24 and 36 months (AUC(6 mo), AUC(24 mo) and AUC(36 mo)) after insertion. For this purpose, blood sampling for pharmacokinetic determination was performed prior to insertion and for up to 3 years afterwards. Bioequivalence was defined as the 90% confidence interval (CI) of the ratio radiopaque implant/non-radiopaque implant of the geometric means (GMR) within the acceptance range of 0.80-1.25. x-Ray visibility was assessed by two-dimensional x-ray imaging after insertion and before removal of the implant. The pharmacokinetic profiles of ENG indicated that the radiopaque and non

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

    Science.gov (United States)

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

    2013-09-08

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

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

    Science.gov (United States)

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

    2013-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Radicioni M

    2017-04-01

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

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

    Science.gov (United States)

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

    2004-12-01

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

  10. A sensitive and robust lc-ms/ms method with monolithic column and electrospray ionization for the quantitation of efavirenz in human plasma: application to a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Danilo Cesar Galindo Bedor

    2011-01-01

    Full Text Available An LC-MS/MS method has been developed for the determination of efavirenz (EFZ in human plasma using hydrochlorothiazide as internal standard (I.S.. An ESI negative mode with multiple reaction-monitoring was used monitoring the transitions m/z 313.88→69.24 (EFZ and 296.02→204.76 (I.S.. Samples were extracted using liquid-liquid extraction. The total run time was 2.0 min. The separation was achieved with HPLC-RP using a monolithic column. The assay was linear in the concentration range of 100 - 5000 ng mL-1. The mean recovery was 83%. Intra- and inter-day precision were < 9.5% and < 8.9%, respectively and accuracy was in the range ± 8.33%. The method was successfully applied to a bioequivalence study.

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

    Science.gov (United States)

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

    2017-01-01

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

  12. Randomized two-way cross-over bioequivalence study of two amoxicillin formulations and inter-ethnicity pharmacokinetic variation in healthy Malay volunteers.

    Science.gov (United States)

    Liew, Kai Bin; Loh, Gabriel Onn Kit; Tan, Yvonne Tze Fung; Peh, Kok Khiang

    2014-09-01

    The objectives of this study were to develop a new deproteinization method to extract amoxicillin from human plasma and evaluate the inter-ethnic variation of amoxicillin pharmacokinetics in healthy Malay volunteers. A single-dose, randomized, fasting, two-period, two-treatment, two-sequence crossover, open-label bioequivalence study was conducted in 18 healthy Malay adult male volunteers, with one week washout period. The drug concentration in the sample was analyzed using high-performance liquid chromatography (UV-vis HPLC). The mean (standard deviation) pharmacokinetic parameter results of Moxilen® were: peak concentration (Cmax ), 6.72 (1.56) µg/mL; area under the concentration-time graph (AUC0-8 ), 17.79 (4.29) µg/mL h; AUC0-∞ , 18.84 (4.62) µg/mL h. Those of YSP Amoxicillin® capsule were: Cmax , 6.69 (1.44) µg/mL; AUC0-8 , 18.69 (3.78) µg/mL h; AUC00-∞ , 19.95 (3.81) µg/mL h. The 90% confidence intervals for the logarithmic transformed Cmax , AUC0-8 and AUC0-∞ of Moxilen® vs YSP Amoxicillin® capsule was between 0.80 and 1.25. Both Cmax and AUC met the predetermined criteria for assuming bioequivalence. Both formulations were well tolerated. The results showed significant inter-ethnicity variation in pharmacokinetics of amoxicillin. The Cmax and AUC of amoxicillin in Malay population were slightly lower compared with other populations. Copyright © 2014 John Wiley & Sons, Ltd.

  13. Bioequivalence studies for 2 different strengths of irbesartan/hydrochlorothiazide combination in healthy volunteers: 300/25 mg and 300/12.5 mg film-coated tablets.

    Science.gov (United States)

    Cánovas, M; Cabré, F; Polonio, F

    2014-05-01

    Two bioequivalence studies of irbesartan (CAS 138402-11-6) and hydrochlorothiazide (CAS 58-93-5) combination at 300/12.5 mg and 300/25 mg strengths were carried out in order to assess the bioequivalence of these film-coated tablet formulations in comparison with the marketed reference formulations.Both studies were performed with 30 healthy volunteers according to an open label, randomized, 2-period, 2-sequence, crossover, single dose and fasting conditions design. In each study, test and reference formulations were administered in 2 treatment days, separated by a washout period of 7 days. Blood samples were drawn up to 72 h following drug administration in case of irbesartan and up to 24 h in case of hydrochlorothiazide. Plasma concentrations of both analytes were obtained by a validated HPLC method using MS/MS detection. Log-transformed AUC0-t and Cmax values were tested for bioequivalence based on the ratios of the geometric LSmeans (test/reference).For both studies, the 90% confidence intervals of the geometric LSmean values for the test/reference ratios for AUC0-t [(irbesartan: 300/12.5 mgstrength: 95.33-111.74%. 300/25 mg strength: 91.27-103.93%) (hydrochlorothiazide: 300/12.5 mg strength: 99.63-107.50%. 300/25 mg strength: 95.72-102.24%)] and Cmax [(irbesartan: 300/12.5 mg strength: 98.73-115.03%. 300/25 mg strength: 97.27-112.12%) (hydrochlorothiazide: 300/12.5 mg strength: 97.34-112.06%. 300/25 mg strength: 93.29-106.38%)] were within the bio-equivalence acceptance range of 80-125%.According to the European Guideline on the Investigation of Bioequivalence it may be therefore concluded that both test formulations are bioequivalent to the corresponding reference formulations. Overall, it was judged that both studies were conducted with a good tolerance of the subjects to study drugs. © Georg Thieme Verlag KG Stuttgart · New York.

  14. 21 CFR 320.21 - Requirements for submission of bioavailability and bioequivalence data.

    Science.gov (United States)

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS... that there may be bioequivalence issues or concerns with the product, FDA may require that the... special patient population, e.g., infants, if clinical studies are required to support the new or...

  15. Estudio de bioequivalencia de clonazepam, tabletas de 2 mg, en voluntarios sanos colombianos Bioequivalence study of clonazepam 2 mg tablets in colombian healthy volunteers

    Directory of Open Access Journals (Sweden)

    Victoria Eugenia Toro Pareja

    2007-08-01

    Full Text Available Con el fin de determinar la bioequivalencia de dos formulaciones de tabletas de 2 mg de clonazepam: Sedatril®/Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia como producto de prueba y Rivotril® (Roche Químicos e Farmacéuticas S. A., Río de Janeiro, Brasil, como producto de referencia, se realizó un estudio de bioequivalencia en 26 voluntarios sanos. Los productos de prueba y de referencia se administraron en condiciones de ayuno de acuerdo con un diseño cruzado aleatorio de dosis única, con dos secuencias, dos tratamientos y un período de lavado de 28 días. Las muestras de sangre se obtuvieron desde las 0 hasta las 96 horas después de la administración del medicamento. Los niveles plasmáticos de clonazepam se determinaron con un método validado por cromatografía líquida de alta eficiencia con detección ultravioleta (HPLC/UV, siglas en inglés. Los parámetros farmacocinéticos ABC0-96, ABC0-∞, Cmax, Tmax, t1/2, and ke se determinaron de los perfiles plasmáticos concentración-tiempo por el método no compartimental. El test de bioequivalencia se realizó con los datos transformados a logaritmo natural (ln de ABC0-∞and Cmax. Los intervalos de confianza del 90% para la relación producto de prueba/producto de referencia fueron de 87,9% a 103,6% y 84,4% a 104,0%, respectivamente. Estos resultados estuvieron dentro de los rangos de aceptación del 80,0% al 125%, establecidos por la FDA y se concluyó que ambos productos son bioequivalentes. In order to determine the bioequivalence of two formulations of clonazepam 2 mg tablets: Sedatril®/ Clonazepam MK (Tecnoquímicas S. A., Cali, Colombia as a test product and Rivotril® (Roche Químicos e Farmacêuticas S. A., Rio de Janeiro, Brazil as a reference product, a bioavailability study was performed in 26 healthy volunteers. Test and reference products were administered under fasting conditions following a single dose, two-sequences, two treatments, crossover randomized

  16. Bioequivalence study between a fixed-dose single-pill formulation of nebivolol plus hydrochlorothiazide and separate formulations in healthy subjects using high-performance liquid chromatography coupled to tandem mass spectrometry.

    Science.gov (United States)

    Vespasiano, Celso Francisco Pimentel; Laurito, Tiago Luders; Iwamoto, Renan Donomae; Moreno, Ronilson Agnaldo; Mendes, Gustavo D; De Nucci, Gilberto

    2017-05-01

    Systemic arterial hypertension is a major risk factor for cerebrovascular disease. Therefore, adequate control of blood pressure is of enormous importance. One of the many fixed-dose single-pill antihypertensive formulations available on the market is the combination of nebivolol and hydrochlorothiazide. The objective of this study was to develop two distinct high-performance liquid chromatography coupled to tandem mass spectrometry methods to simultaneously quantify nebivolol and hydrochlorothiazide in human plasma. The methods were employed in a bioequivalence study, the first assay involving a nebivolol fixed-dose single-pill formulation based on healthy Brazilian volunteers. Nebilet HCT™ (nebivolol 5 mg + hydrochlorothiazide 12.5 mg tablet, manufactured by Menarini) was the test formulation. The reference formulations were Nebilet™ (nebivolol 5 mg tablet, manufactured by Menarini) and Clorana™ (hydrochlorothiazide 25 mg tablet, manufactured by Sanofi). For both analytes, liquid-liquid extraction was employed for sample preparation and the chromatographic run time was 3.5 min. The limits of quantification validated were 0.02 ng/mL for nebivolol and 1 ng/mL for hydrochlorothiazide. Since the 90% CI for C max , AUC (0-last) and AUC (0-inf) individual test/reference ratios were within the 80-125% interval indicative of bioequivalence, it was concluded that Nebilet HCT™ is bioequivalent to Nebilet™ and Clorana™. Copyright © 2016 John Wiley & Sons, Ltd.

  17. 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.

  18. Development and validation of an improved method for the quantitation of sertraline in human plasma using LC-MS-MS and its application to bioequivalence studies.

    Science.gov (United States)

    Zhang, Mengliang; Gao, Feng; Cui, Xiangyong; Zhang, Yunhui; Sun, Yantong; Gu, Jingkai

    2011-02-01

    A rapid and sensitive LC-MS-MS method for the quantitation of sertraline in human plasma was developed and validated. Sertraline and the internal standard, telmisartan, were cleaned up by protein precipitation from 100 μL of plasma sample, and analyzed on a TC-C18 column (5 μm, 150 × 4.6 mm i.d.) using 70% acetonitrile and 30% 10 mM ammonium acetate (0.1% formic acid) as mobile phase. The method was demonstrated to be linear from 0.1 ng/mL to 50 ng/mL with the lower limit of quantitation of 0.1 ng/mL. Intra- and inter-day precision were below 4.40% and 3.55%. Recoveries of sertraline at low, medium, and high levels were 88.0 ± 2.3%, 88.2 ± 1.9%, and 90.0 ± 2.0%, respectively. The method was successfully applied to a bioequivalence study of sertraline after a single oral administration of 50 mg sertraline hydrochloride tablets.

  19. Simultaneous determination of irbesartan and hydrochlorothiazide in human plasma by ultra high performance liquid chromatography tandem mass spectrometry and its application to a bioequivalence study.

    Science.gov (United States)

    Qiu, Xiangjun; Wang, Zhe; Wang, Bing; Zhan, Hui; Pan, Xiaofeng; Xu, Ren-ai

    2014-04-15

    An ultra high performance liquid chromatography tandem mass spectrometry (U-HPLC-MS/MS) method was developed and validated to determine irbesartan (IRB) and hydrochlorothiazide (HCTZ) in human plasma simultaneously. Plasma samples were prepared using protein precipitation with acetonitrile, the two analytes and the internal standard losartan were separated on an Acquity U-HPLC BEH C18 column and mass spectrometric analysis was performed using a QTrap5500 mass spectrometer coupled with an electro-spray ionization (ESI) source in the negative ion mode. The MRM transitions of m/z 427.2→206.9 and m/z 296.1→204.9 were used to quantify for IRB and HCTZ, respectively. The linearity of this method was found to be within the concentration range of 5-3000ng/mL for IRB, and 0.5-300ng/mL for HCTZ in human plasma, respectively. The lower limit of quantification (LLOQ) was 5ng/mL and 0.5ng/mL for IRB and HCTZ in human plasma, respectively. The relative standard deviations (RSD) of intra and inter precision were less than 12% for both IRB and HCTZ. The analysis time of per sample was 2.5min. The developed and validated method was successfully applied to a bioequivalence study of IRB (300mg) with HCTZ (12.5mg) tablet in Chinese healthy volunteers (N=20). Copyright © 2014 Elsevier B.V. All rights reserved.

  20. Application of a rapid and sensitive liquid chromatography-tandem mass spectrometry method for determination of bumetanide in human plasma for a bioequivalence study.

    Science.gov (United States)

    Patel, Dinesh S; Sharma, Naveen; Patel, Mukesh C; Patel, Bhavin N; Shrivastav, Pranav S; Sanyal, Mallika

    2012-07-01

    A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of bumetanide in human plasma using tamsulosin as internal standard (IS). The analyte and IS were extracted from 200 μL of human plasma via solid phase extraction and the chromatographic separation was achieved on Peerless Basic C18 (100 mm × 4.6 mm, 3 μm) column under isocratic conditions. Detection of bumetanide and IS was done by tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for bumetanide and IS were m/z 365.2→240.2 and 409.2→228.2 respectively. The method was fully validated as per the US FDA guidelines. The limit of detection and lower limit of quantitation of the method were 0.03 and 0.30 ng/mL respectively with a linear dynamic range of 0.30-200.0 ng/mL for bumetanide. The intra-batch and inter-batch precision (% CV) was ≤6.9% while the mean extraction recovery was >90% across quality control levels. The method is selective in presence of four diuretic drugs and some commonly used medications by healthy volunteers. It was successfully applied to a bioequivalence study of 2mg bumetanide tablet formulation in 10 healthy Indian male subjects under fasting condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 42 incurred samples. Copyright © 2012 Elsevier B.V. All rights reserved.

  1. A simple and sensitive HPLC method for analysis of imipramine in human plasma with UV detection and liquid-liquid extraction: Application in bioequivalence studies.

    Science.gov (United States)

    Rezazadeh, Mahboubeh; Emami, Jaber

    2016-01-01

    High-performance liquid chromatography (HPLC) methods employing ultraviolet (UV) detector are not sufficiently sensitive to measure the low plasma concentrations following single oral dose of imipramine. Therefore, in the present study a simple, rapid and yet sensitive HPLC method with UV detection was developed and validated for quantitation of imipramine in human plasma samples. An efficient liquid-liquid extraction (LLE) of imipramine from plasma with the mixture of hexane/isoamyl alcohol (98:2) and back extraction of the drug in acidic medium concomitant with evaporation of organic phase allowed the use of UV detector to conveniently measure plasma levels of this compound as low level as 3 ng/ml. Separation was achieved on a μ-Bondapak C18 HPLC column using sodium hydrogen phosphate solution (0.01 M)/acetonitrile (60/40 v/v) at pH 3.5 ± 0.1 at 1.5 ml/min. Trimipramine was used as the internal standard for analysis of plasma samples. The retention times for imipramine and trimipramine were 4.3 and 5.2 min, respectively. Calibration curve was linear in the range of 3-40 ng/ml using human plasma with the average extraction recovery of 85 ± 5%. Imipramine was found to be stable in plasma samples with no evidence of degradation during three freeze-thaw cycles and three months storage at -70°C. The current validated method was finally applied in bioequivalence studies of two different imipramine products according to a standard two-way crossover design with a two weeks washout period.

  2. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Science.gov (United States)

    2013-08-02

    ...] Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories... (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories... the availability of a draft guidance on mesalamine (Draft Mesalamine Rectal Suppository BE...

  3. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Science.gov (United States)

    2013-12-05

    ... Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and Drug... Paliperidone Palmitate.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release...

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

    Directory of Open Access Journals (Sweden)

    Pravin G. Vanol

    2016-08-01

    Full Text Available A rapid and sensitive ultra performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS method is described for determination of letrozole in human plasma. Following solid phase extraction (SPE of letrozole and letrozole-d4 on Orochem DVB-LP cartridges, chromatography was performed on Acquity UPLC BEH C18 (50 mm×2.1 mm, 1.7 µm column using methanol-0.1% formic acid in water (85:15, v/v as the mobile phase. Detection was carried out on a triple quadrupole mass spectrometer with an electrospray source, operated under positive ionization mode. Quantitation of letrozole and letrozole-d4 was done using multiple reaction monitoring (MRM following the transitions at m/z 286.2→217.0 and m/z 290.2→221.0, respectively. The calibration plots were linear through the concentration range of 0.10–100 ng/mL (r2≥0.9990 using 100 µL human plasma. The extraction recovery of letrozole ranged from 94.3% to 96.2% and the intra-batch and inter-batch precision was ≤5.2%. The method was successfully applied to a bioequivalence study of letrozole after oral administration of 2.5 mg tablet formulation to 16 healthy postmenopausal Indian women. The assay reproducibility was also established through incurred sample reanalysis (ISR of 74 subject samples.

  5. Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Jaivik V. Shah

    2017-10-01

    Full Text Available A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML, valsartan (VAL and hydrochlorothiazide (HCTZ in human plasma by liquid chromatography–tandem mass spectrometry (LC–MS/MS. The analytes and their deuterated analogs were quantitatively extracted from 100 µL human plasma by solid phase extraction on Oasis HLB cartridges. The chromatographic separation of the analytes was achieved on a Chromolith RP18e (100 mm × 4.6 mm analytical column within 2.5 min. The resolution factor between AML and VAL, AML and HCTZ, and VAL and HCTZ was 2.9, 1.5 and 1.4, respectively, under isocratic conditions. The method was validated over a dynamic concentration range of 0.02–20.0 ng/mL for AML, 5.00–10,000 ng/mL for VAL and 0.20–200 ng/mL for HCTZ. Ion-suppression/enhancement effects were investigated by post-column infusion technique. The mean IS-normalized matrix factors for AML, VAL and HCTZ were 0.992, 0.994 and 0.998, respectively. The intra-batch and inter-batch precision (% CV across quality control levels was ≤ 5.56% and the recovery was in the range of 93.4%–99.6% for all the analytes. The method was successfully applied to a bioequivalence study of 5 mg AML + 160 mg VAL + 12.5 mg HCTZ tablet formulation (test and reference in 18 healthy Indian males under fasting. The mean log-transformed ratios of Cmax, AUC0–120h and AUC0-inf and their 90% CIs were within 90.2%–102.1%. The assay reproducibility was demonstrated by reanalysis of 90 incurred samples.

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

    Science.gov (United States)

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

    2015-09-01

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

  7. Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

    Directory of Open Access Journals (Sweden)

    Zhang Y

    2017-07-01

    Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

  8. Bioequivalence of three florfenicol preparations in broilers

    Directory of Open Access Journals (Sweden)

    Husamettin Ekici

    2014-12-01

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

  9. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects.

    Science.gov (United States)

    Kang, Woo Youl; Seong, Sook Jin; Ohk, Boram; Gwon, Mi-Ri; Kim, Bo Kyung; La, Sookie; Kim, Hyun-Ju; Cho, Seungil; Yoon, Young-Ran; Yang, Dong Heon; Lee, Hae Won

    2018-01-01

    A new fixed-dose combination (FDC) formulation of telmisartan 80 mg and S-amlodipine 5 mg (CKD-828) has been developed to increase convenience (as only one tablet is required per day) and improve treatment compliance. The pharmacokinetic characteristics and tolerability of an FDC of telmisartan and S-amlodipine were compared to those after coadministration of the individual agents in this randomized, open-label, single-dose, two-way, four-period, crossover study. To analyze the telmisartan and S-amlodipine plasma concentrations using a validated liquid chromatography-tandem mass spectrometry method, serial blood samples were collected up to 48 hours post-dose for telmisartan and 144 hours post-dose for S-amlodipine, in each period. Forty-eight healthy subjects were enrolled, and 43 completed the study. The mean peak plasma concentration (C max ) and the area under the plasma concentration-time curve from time 0 to the last measurement (AUC 0-t ) values of telmisartan were 522.29 ng/mL and 2,475.16 ng·h/mL for the FDC, and 540.45 ng/mL and 2,559.57 ng·h/mL for the individual agents concomitantly administered, respectively. The mean C max and AUC 0-t values of S-amlodipine were 2.71 ng/mL and 130.69 ng·h/mL for the FDC, and 2.74 ng/mL and 129.81 ng·h/mL for the individual agents concomitantly administered, respectively. The geometric mean ratio (GMR) and 90% confidence interval (CI) for the telmisartan C max and AUC 0-t (FDC of telmisartan and S-amlodipine/concomitant administration) were 0.8509 (0.7353-0.9846) and 0.9431 (0.8698-1.0226), respectively. The GMR and 90% CI for the S-amlodipine C max and AUC 0-t (FDC/concomitant administration) were 0.9829 (0.9143-1.0567) and 0.9632 (0.8798-1.0546), respectively. As the intrasubject variability of the C max for telmisartan administered individually was 42.94%, all 90% CIs of the GMRs fell within the predetermined acceptance range. Both treatments were well tolerated in this study. CKD-828 FDC tablets were shown to

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

    Science.gov (United States)

    Martínez González, Javier; Monreal, Mayte; Ayani Almagia, Ignacio; Llaudó Garín, Jordi; Ochoa Díaz de Monasterioguren, Lourdes; Gutierro Adúriz, Ibón

    2018-01-01

    To demonstrate the pharmacokinetic/pharmacodynamic (PK/PD) equivalence of a biosimilar enoxaparin to the reference drug, and to assess its safety and tolerability in healthy volunteers. A randomized, double-blind, crossover, 2-sequence, single-dose study was conducted in healthy volunteers of both sexes. Participants were sequentially and randomly administered single subcutaneous injections of enoxaparin 100 mg manufactured by Rovi (test; Madrid, Spain) and Clexane ® (enoxaparin 100 mg manufactured by Sanofi, reference) separated by a 1-week washout period. The primary PK/PD variables were maximum activity (A max ) and area under the effect curve from time 0 to the last measured activity (T) (AUEC 0-T ) and AUEC from time 0 to infinity (AUEC 0-inf ) of anti-FXa activity, and A max and AUEC 0-T of anti-FIIa activity. Secondary variables were A max and AUEC 0-T , AUEC 0-inf of tissue factor pathway inhibitor, and the ratio of AUEC 0-T anti-FXa to anti-FIIa activity. Biosimilarity would be shown when the 95% CI of the ratio of geometric least squares means (95% CI RGLSMs) of primary PK/PD parameters fell within the standard range of bioequivalence, ie, 80%-125%. The study sample consisted of 46 volunteers (33 males) aged 18-44 years and with body mass index ranging from 19.0 to 31.1 kg/m 2 . Three subjects did not complete the study. The curves of anti-FXa, anti-FIIa and tissue factor pathway inhibitor activities corresponding to administration of the test and reference products were comparable. The 95% CI RGLSMs of A max , AUEC 0-T and AUEC 0-inf for anti-FXa activity were 94.6%-105.9%, 99.8%-108.0% and 100.0%-108.6% respectively; A max and AUEC 0-T for anti-FIIa activity were 94.7%-112.6% and 90.9%-117.9% respectively. In addition, the 95% CI RGLSMs of all secondary variables fell within the range 80%-125%. The incidence and types of adverse events after administration of the test and reference drugs were similar. The results conclusively showed that the enoxaparin

  11. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3).

    Science.gov (United States)

    Stavchansky, Salomon

    2008-06-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

  12. 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.

  13. The steady-state serum concentration of genistein aglycone is affected by formulation: a bioequivalence study of bone products.

    Science.gov (United States)

    Bitto, Alessandra; Burnett, Bruce P; Polito, Francesca; Russo, Silvia; D'Anna, Rosario; Pillai, Lakshmi; Squadrito, Francesco; Altavilla, Domenica; Levy, Robert M

    2013-01-01

    An FDA-regulated, prescription medical food (Fosteum; 27 mg natural genistein, 200 IU cholecalciferol, 20 mg citrated zinc bisglycinate (4 mg elemental zinc) per capsule) and an over-the-counter (OTC) supplement (Citracal Plus Bone Density Builder; 27 mg synthetic genistein, 600 mg elemental calcium (calcium citrate), 400 IU vitamin D3, 50 mg magnesium, 7.5 mg zinc, 1 mg copper, 75 μ g molybdenum, 250 μ g boron per two tablets) were compared to a clinically proven bone formulation (27 mg natural genistein, 400 IU cholecalciferol, 500 mg elemental calcium (calcium carbonate) per tablet; the Squadrito formulation) in an 8-day steady-state pharmacokinetic (PK) study of healthy postmenopausal women (n = 30) randomized to receive 54 mg of genistein per day. Trough serum samples were obtained before the final dose on the morning of the ninth day followed by sampling at 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hrs. Total serum genistein, after β -glucuronidase/sulfatase digestion, was measured by time-resolved fluorometric assay. Maximal time (Tmax), concentration (Cmax), half-life (T1/2), and area under the curve (AUC) were determined for genistein in each formulation. Fosteum and the Squadrito study formulation were equivalent for genistein Tmax (2 hrs), Cmax (0.7 μM), T1/2 (18 ± 6.9 versus 21 ± 4.9 hrs), and AUC (9221 ± 413 versus 9818 ± 1370 ng·hr/mL). The OTC supplement's synthetically derived genistein, however, showed altered Tmax (6 hrs), Cmax (0.57 μ M), T1/2 (8.3 ± 1.9 hrs), and AUC (6474 ± 287 ng·hr/mL). Differences in uptake may be due to multiple ingredients in the OTC supplement which interfere with genistein absorption.

  14. The Steady-State Serum Concentration of Genistein Aglycone Is Affected by Formulation: A Bioequivalence Study of Bone Products

    Directory of Open Access Journals (Sweden)

    Alessandra Bitto

    2013-01-01

    Full Text Available An FDA-regulated, prescription medical food (Fosteum; 27 mg natural genistein, 200 IU cholecalciferol, 20 mg citrated zinc bisglycinate (4 mg elemental zinc per capsule and an over-the-counter (OTC supplement (Citracal Plus Bone Density Builder; 27 mg synthetic genistein, 600 mg elemental calcium (calcium citrate, 400 IU vitamin D3, 50 mg magnesium, 7.5 mg zinc, 1 mg copper, 75 μg molybdenum, 250 μg boron per two tablets were compared to a clinically proven bone formulation (27 mg natural genistein, 400 IU cholecalciferol, 500 mg elemental calcium (calcium carbonate per tablet; the Squadrito formulation in an 8-day steady-state pharmacokinetic (PK study of healthy postmenopausal women (n=30 randomized to receive 54 mg of genistein per day. Trough serum samples were obtained before the final dose on the morning of the ninth day followed by sampling at 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hrs. Total serum genistein, after β-glucuronidase/sulfatase digestion, was measured by time-resolved fluorometric assay. Maximal time (Tmax, concentration (Cmax, half-life (T1/2, and area under the curve (AUC were determined for genistein in each formulation. Fosteum and the Squadrito study formulation were equivalent for genistein Tmax (2 hrs, Cmax (0.7 μM, T1/2 (18±6.9 versus 21±4.9 hrs, and AUC (9221±413 versus 9818±1370 ng·hr/mL. The OTC supplement’s synthetically derived genistein, however, showed altered Tmax (6 hrs, Cmax (0.57 μM, T1/2 (8.3±1.9 hrs, and AUC (6474±287 ng·hr/mL. Differences in uptake may be due to multiple ingredients in the OTC supplement which interfere with genistein absorption.

  15. Pharmacokinetics and bioequivalence evaluation of two different atorvastatin calcium 10-mg tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy fasted Chinese adult males.

    Science.gov (United States)

    Liu, Yan-Mei; Pu, Hua-Hua; Liu, Gang-Yi; Jia, Jing-Ying; Weng, Li-Ping; Xu, Rong-Jing; Li, Guo-Xiu; Wang, Wei; Zhang, Meng-Qi; Lu, Chuan; Yu, Chen

    2010-07-01

    Atorvastatin calcium is a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor indicated for the prevention of cardiovascular disease and for the treatment of dyslipidemia. Information on the pharmacokinetics of atorvastatin in a Chinese population is lacking, and regulatory requirements necessitate a bioequivalence study for the marketing of a generic product in China. The aim of the present study was to assess the pharmacokinetics and bioequivalence of a test and branded reference formulation of atorvastatin calcium 10-mg tablets in healthy fasted Chinese male volunteers. This was a single-dose, randomized-sequence, open-label, 2-period crossover study with a 2-week washout period between doses. Healthy Chinese males were randomly assigned to receive 20 mg of either the test or reference formulation, and 13 blood samples were obtained over a 48-hour interval. Plasma concentrations of parent atorvastatin and ortho-hydroxy-atorvastatin (primary active metabolite) were simultaneously determined using a validated liquid chromatography-isotopic dilution mass spectrometry method. Pharmacokinetic parameters, including C(max), T(max), t((1/2)), AUC(0-t), and AUC(0-infinity)), were calculated. The 2 formulations were to be considered bioequivalent if 90% CIs for the log transformed ratios of AUC and C(max) of atorvastatin were within the predetermined bioequivalence range (0.80-1.25 for AUC and 0.70-1.43 for C(max)) as established by the State Food and Drug Administration of China. Tolerability was evaluated throughout the study by vital signs monitoring, physical examinations, 12-lead ECGs, and subject interviews on adverse events (AEs). A total of 66 subjects were assessed for inclusion; 20 were excluded prior to study initiation. Of the 46 healthy subjects (mean [SD] age, 24.1 [2.5] years; height, 170.8 [5.1] cm; weight, 64.6 [6.4] kg; body mass index (BMI), 22.1 [1.7] kg/m(2)) who completed the study, 45 subjects (mean [SD] age, 24.1 [2.5] years; height, 171.1 [4

  16. Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828 formulation and coadministered telmisartan and S-amlodipine in healthy subjects

    Directory of Open Access Journals (Sweden)

    Kang WY

    2018-03-01

    concomitantly administered, respectively. The mean Cmax and AUC0–t values of S-amlodipine were 2.71 ng/mL and 130.69 ng⋅h/mL for the FDC, and 2.74 ng/mL and 129.81 ng⋅h/mL for the individual agents concomitantly administered, respectively. The geometric mean ratio (GMR and 90% confidence interval (CI for the telmisartan Cmax and AUC0–t (FDC of telmisartan and S-amlodipine/concomitant administration were 0.8509 (0.7353–0.9846 and 0.9431 (0.8698–1.0226, respectively. The GMR and 90% CI for the S-amlodipine Cmax and AUC0–t (FDC/concomitant administration were 0.9829 (0.9143–1.0567 and 0.9632 (0.8798–1.0546, respectively. As the intrasubject variability of the Cmax for telmisartan administered individually was 42.94%, all 90% CIs of the GMRs fell within the predetermined acceptance range. Both treatments were well tolerated in this study. Conclusion: CKD-828 FDC tablets were shown to be bioequivalent to coadministration of the individual agents with the respective strength, in healthy subjects under fasting conditions. There was no significant difference in safety profile between the two treatments. Keywords: fixed-dose combination, pharmacokinetics, S-amlodipine, telmisartan, safety

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

    Directory of Open Access Journals (Sweden)

    Martínez González J

    2018-03-01

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

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

    Science.gov (United States)

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

    2013-03-01

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

  19. Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: a single-dose, randomized, open-label, crossover study.

    Science.gov (United States)

    Di Girolamo, Guillermo; Keller, Guillermo A; de Los Santos, Antonio R; Schere, Daniel; Gonzalez, Claudio D

    2008-11-01

    Levothyroxine has a narrow therapeutic index; therefore, precise and accurate assessment of the bioequivalence of different levothyroxine products is critical. Bioavailability estimates of levothyroxine formulations might be affected by baseline concentrations of the hormone. The aim of this study was to assess the bioequivalence of 100 microg of a test (T4 Montpellier 100, Química Montpellier S.A., Buenos Aires, Argentina) and reference (Synthroid, Abbott Laboratories, Abbott Park, Illinois) formulation of levothyroxine. We also compared 2 methods of levothyroxine measurements: without and with baseline correction for endogenous levothyroxine. This randomized, open-label, 2-sequence, crossover study with a 65-day washout period was carried out in healthy, white, euthyroid volunteers following a single dose of sodium levothyroxine 600 microg. Blood samples were collected at 30 and 15 minutes prior to administration, and 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, and 48 hours to determine thyroxine; serum thyrotropin (TSH) concentrations were determined 30 minutes before administration and 48 hours after administration. Serum concentrations of thyroxine were determined through radioimmunoassay and serum TSH concentrations were determined by a validated 2-site immunoradiometric assay. The formulations are considered to be equivalent if the 90% CI ratios for C(max) and AUC(0-last) are within 80% to 125%, per the US Food and Drug Administration (FDA). Adverse event monitoring was performed throughout the study by assessing clinical parameters (eg, blood pressure, electrocardiogram) and patient reports. A total of 24 volunteers (16 male, 8 female; mean [SD] age, 30.2 [4.6] years [range, 21-40 years]; mean [SD] weight, 71.71 [7.52] kg [range, 58-83 kg]) were included in the study. Without adjustment for baseline levels of endogenous levothyroxine, geometric mean C(max) for the test and reference formulations were 8.92 and 9.39 microg/dL, respectively

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

    Directory of Open Access Journals (Sweden)

    Bhupinder Singh

    2014-04-01

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

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

    Science.gov (United States)

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

    2017-05-20

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

  2. 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.

  3. Topical safety and vasoconstrictive assay-based bioequivalence of a new reformulated mometasone cream.

    Science.gov (United States)

    Krishna, Rajesh; Horowitz, Ann; Larson, Patrick; Bolognese, James; Marcantonio, Eugene E

    2017-07-01

    A new improved mometasone furoate (Elocon™) cream with an emulsification system that produces a stable emulsion has been developed. In order to register the product in various markets, it was essential to ensure the cream was topically well tolerated and that it was bioequivalent to the reference product. Phase I clinical studies were performed to assess the local safety and tolerability upon multiple dosing of this new cream as well as to assess the single-dose bioequivalence relative to the marketed product. Bioequivalence was assessed using a vasoconstrictive assay (VCA) after a dose-duration pilot study was completed with the marketed Elocon cream. The new mometasone cream and its vehicle were nonirritating in healthy subjects during 21-day patch application (MCII cream in various markets.

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

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

    2017-12-05

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

  6. The bootstrap and Bayesian bootstrap method in assessing bioequivalence

    International Nuclear Information System (INIS)

    Wan Jianping; Zhang Kongsheng; Chen Hui

    2009-01-01

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

  7. Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results.

    Science.gov (United States)

    Cai, Gengqian; Thiessen, Jake J; Baidoo, Charlotte A; Fossler, Michael J

    2010-10-01

    Studies to establish bioequivalence (BE) of a drug are important elements in support of drug applications. A typical BE study is conducted as a single dose, randomized, 2-period crossover design. For drugs with long half lives (≥ 48 hours) and evaluation of multiple BE objectives in 1 trial, this design may not be adequate. A parallel design may then be a more appropriate choice. However, parallel designs require increased sample size, which can become substantial. One option that is a compromise between the complete randomized block design and the parallel design is a partial-block crossover design. This approach came about during the development of a combination of dutasteride and tamsulosin. Previous experience with performing single-dose dutasteride studies suggested that 28 days of washout is needed between treatments because of its half-life of 7-9 days. Simulations were performed to assess the operating characteristics of this design using a previously developed PK model. Four scenarios were developed, and each scenario was simulated 500 times. The results showed that this design demonstrated acceptable consumer and producer risk. Partial-block crossover designs should be considered for studies when the half-life of the drug is long and there are more than 2 periods.

  8. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2013-11-06

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

  9. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-09-14

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

  10. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Science.gov (United States)

    2010-06-11

    ... describes a new process for making available recommendations on how to design product- specific... guidance describes a new process for making available recommendations on how to design product-specific BE... guidance on how to design product-specific bioequivalence studies to support ANDAs. It does not create or...

  11. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Science.gov (United States)

    2012-03-22

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

  12. Topical bioequivalence of acyclovir creams using dermal microdialysis in pigs: a new model to evaluate bioequivalence for topical formulations.

    Science.gov (United States)

    Wei, Huilin; Wang, Shuqi; Xu, Feng; Xu, Lanfang; Zheng, Jiarun; Chen, Yun

    2012-07-01

    The aim was to evaluate the bioequivalence of topically applied Acyclovir (ACV) creams using dermal microdialysis (DMD) in a pig model. Three ACV creams (3%), ACV1, ACV2 and ACV3, were topically administrated on the dorsum of pigs, and the DMD sampling technique was used to continuously collect microdialysate. The concentration of ACV in microdialysate was measured by HPLC and the concentration-time profiles were used to calculate pharmacokinetic parameters. The results showed that 90% confidence interval (CI) of the ratio of AUC(0-4 h) of ACV2 and ACV3 was between 88.2 and 105.7%, which was within the acceptance range (80-125%). Ninety percent CI of the ratio of C(max) of ACV2 and ACV3 was between 87.4 and 124.4%, which was within the acceptance range (80-125%). These data indicate that ACV2 and ACV3 used in this study were bioequivalent. This study demonstrates that the pig model coupled with DMD sampling can potentially provide a cost-effective strategy to evaluate topical drug delivery and its associated pharmacokinetic studies.

  13. Assessment of topical bioequivalence using dermal microdialysis and tape stripping methods.

    Science.gov (United States)

    Incecayir, Tuba; Agabeyoglu, Ilbeyi; Derici, Ulver; Sindel, Sukru

    2011-09-01

    To assess the bioequivalence of two commercial topical formulations of oxytetracycline HCl by tape stripping and microdialysis in healthy volunteers. Tape stripping study was conducted on 12 healthy volunteers. After a 30-minute application of the formulations, adhesive tapes were used to sample stratum corneum at 0.25, 0.5, 1, 1.5, 2, 3, 4 hr. Ten of these volunteers were included in the microdialysis study with a period of 4 weeks between the experiments. Microdialysis probes were inserted into the dermis of the forearm. Following the application of the test and reference simultaneously, dialysates were collected in 30-minute sampling intervals up to 4 hr. Pharmacokinetic evaluation by microdialysis yielded that the test could not be said to be bioequivalent to the reference at 90% CI. The intersubject variability of oxytetracycline content in stratum corneum was moderate when it was compared to the dermal levels. The test was found to be bioequivalent to reference according to the dermatopharmacokinetic evaluation by tape stripping. No significant correlations were found between microdialysis and tape stripping methods as regarding the topical bioequivalence of oxytetracycline HCl formulations.

  14. Electron microscope studies

    International Nuclear Information System (INIS)

    Crewe, A.V.; Kapp, O.H.

    1990-01-01

    Our laboratory has made significant progress this year in devising improved electron-optical systems, in studying invertebrate hemoglobins with the STEM, and in achieving a workable sub-angstrom STEM. Our goal in electron optics is to improve resolution by producing spherical and chromatic aberration coefficients with signs opposite those of magnetic lenses. We have progressed toward this goal through calculations that explore the addition of electrodes to electron mirrors to reduce these two geometric aberrations and by devising a beam separation system that won't introduce asymmetrical aberrations. Some promising new designs of magnetic lenses for SEM applications have also been investigated. We have continued our exploration of the quaternary structure of the invertebrate hemoglobins and are now among the top laboratories in this area of expertise. In addition, we have overcome many of our electronic difficulties on the sub-angstrom STEM and have made significant progress toward achieving an operational system. The addition of an IBM RISC-6000 workstation to our lab has significantly increased our image processing capabilities

  15. Bioavailability and bioequivalence: focus on physiological factors and variability.

    Science.gov (United States)

    Karalis, Vangelis; Macheras, Panos; Van Peer, Achiel; Shah, Vinod P

    2008-08-01

    This is a summary report of the EUFEPS & COST B25 conference on Bioavailability and Bioequivalence which focused on physiological factors and variability. This conference was held at The Royal Olympic Hotel in the centre of Athens (Greece) during the 1-2 of October in 2007. The issues discussed in the conference involved physiological factors affecting drug absorption, the role of pre-systemic effects on bioavailability (BA), the impact of variability in bioequivalence (BE) studies, and a final closing panel session on unresolved issues in BA/BE regulations. Several important aspects of drug absorption were highlighted. It was presented how the complexity of gastrointestinal (GI) physiology and the site dependent absorption can impact on drug BA. Similarly, the effects of food and formulation were also studied. The second session focused on integrating the complexities of GI into modeling the inter-individual variability of absorption and the prediction of first-pass metabolism from in-vitro data. The necessity to measure metabolites, the value of Biopharmaceutical Classification System (BCS), and the more recently proposed Biopharmaceutical Drug Disposition Classification System (BDDCS) were assessed as well. This session closed with presentations of pharmacokinetic software delegates. In the second day of the conference, the problem of high intra-subject variability in BE studies was analyzed. Study design considerations, the use of multiple-dose studies and the role of statistics in BE were also highlighted. Finally, the current thinking of regulatory authorities (EMEA and US-FDA) was presented. The conference closed with a last session on unresolved issues in the regulatory level.

  16. Pharmacokinetic properties and bioequivalence of two compound formulations of 1500 mg ampicillin (1167 mg)/probenecid (333 mg): a randomized-sequence, single-dose, open-label, two-period crossover study in healthy Chinese male volunteers.

    Science.gov (United States)

    Wu, Huizhe; Liu, Mingyan; Wang, Shuang; Feng, Wanyu; Yao, Weifan; Zhao, Haishan; Wei, Minjie

    2010-03-01

    Ampicillin/probenecid is an antimicrobial formulation indicated for the treatment of respiratory, urinary tract, and gastrointestinal infections. Ampicillin sodium is the active antimicrobial ingredient that can act on the phase of bacterial breeding and inhibit the biosynthesis of bacterial mucopeptide in the cell wall. Probenecid acts synergistically by competitively inhibiting an organic anion transporter in renal tubules, increasing the plasma concentrations, and thus extending the plasma elimination t(1/2). The aim of this study was to assess and compare the pharmacokinetic (PK) properties, bioavailability, and bioequivalence of a newly developed dispersible tablet formulation (test) of ampicillin/ probenecid with those of an established branded capsule formulation (reference) in healthy Chinese male volunteers. A randomized-sequence, single-dose, open-label, 2-period crossover study was conducted in fasted healthy Chinese male volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 6 dispersible tablets (test) or branded capsules (reference) (1500 mg total; 250 mg each containing ampicillin 194.5 mg and probenecid 55.5 mg), followed by a 7-day washout period and administration of the alternate formulation. Plasma samples were collected over a 24-hour period following administration and analyzed for ampicillin and probenecid content by HPLC. PK parameters such as C(max), AUC(0-t), and AUC(0-infinity) were also determined. The formulations were considered bioequivalent if the geometric mean ratios of the log-transformed C(max) and AUC values were within the equivalence range (80%-125%) predetermined by the State Food and Drug Administration (SFDA) of the People's Republic of China. Tolerability was based on the observation of adverse events (AEs), monitoring of vital signs (blood pressure, heart rate, temperature, electrocardiography) and laboratory tests (hematology, blood biochemistry, hepatic function, urinalysis), and subject

  17. Quantification of strontium in human serum by ICP-MS using alternate analyte-free matrix and its application to a pilot bioequivalence study of two strontium ranelate oral formulations in healthy Chinese subjects.

    Science.gov (United States)

    Zhang, Dan; Wang, Xiaolin; Liu, Man; Zhang, Lina; Deng, Ming; Liu, Huichen

    2015-01-01

    A rapid, sensitive and accurate ICP-MS method using alternate analyte-free matrix for calibration standards preparation and a rapid direct dilution procedure for sample preparation was developed and validated for the quantification of exogenous strontium (Sr) from the drug in human serum. Serum was prepared by direct dilution (1:29, v/v) in an acidic solution consisting of nitric acid (0.1%) and germanium (Ge) added as internal standard (IS), to obtain simple and high-throughput preparation procedure with minimized matrix effect, and good repeatability. ICP-MS analysis was performed using collision cell technology (CCT) mode. Alternate matrix method by using distilled water as an alternate analyte-free matrix for the preparation of calibration standards (CS) was used to avoid the influence of endogenous Sr in serum on the quantification. The method was validated in terms of selectivity, carry-over, matrix effects, lower limit of quantification (LLOQ), linearity, precision and accuracy, and stability. Instrumental linearity was verified in the range of 1.00-500ng/mL, corresponding to a concentration range of 0.0300-15.0μg/mL in 50μL sample of serum matrix and alternate matrix. Intra- and inter-day precision as relative standard deviation (RSD) were less than 8.0% and accuracy as relative error (RE) was within ±3.0%. The method allowed a high sample throughput, and was sensitive and accurate enough for a pilot bioequivalence study in healthy male Chinese subjects following single oral administration of two strontium ranelate formulations containing 2g strontium ranelate. Copyright © 2014 Elsevier GmbH. All rights reserved.

  18. Bioequivalence: the regulatory career of a pharmaceutical concept.

    Science.gov (United States)

    Carpenter, Daniel; Tobbell, Dominique A

    2011-01-01

    Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history of bioequivalence, which emphasizes the shaping role of the state upon scientific processes, networks of regulators and scientists, and the centrality of transnational dynamics in the formation of drug regulatory standards.

  19. Electron microscope studies

    International Nuclear Information System (INIS)

    Crewe, A.V.; Kapp, O.H.

    1991-01-01

    This year our laboratory has continued to make progress in the design of electron-optical systems, in the study of structure-function relationships of large multi-subunit proteins, in the development of new image processing software and in achieving a workable sub-angstrom STEM. We present an algebraic approach to the symmetrical Einzel (unipotential) lens wherein we simplify the analysis by specifying a field shape that meets some preferred set of boundary or other conditions and then calculate the fields. In a second study we generalize this approach to study of three element electrostatic lenses of which the symmetrical Einzel lens is a particular form. The purpose is to develop a method for assisting in the design of a lens for a particular purpose. In our biological work we study a stable and functional dodecameric complex of globin chains from the hemoglobin of Lumbricus terrestris. This is a complex lacking the ''linker'' subunit first imaged in this lab and required for maintenance of the native structure. In addition, we do a complete work-up on the hemoglobin of the marine polychaete Eudistylia vancouverii demonstrating the presence of a hierarchy of globin complexes. We demonstrate stable field-emission in the sub-angstrom STEM and the preliminary alignment of the beam. We continue our exploration of a algorithms for alignment of sequences of protein and DNA. Our computer facilities now include four second generation RISC workstations and we continue to take increasing advantage of the floating-point and graphical performance of these devices

  20. Electron microscope studies

    Energy Technology Data Exchange (ETDEWEB)

    Crewe, A.V.; Kapp, O.H.

    1991-06-01

    This year our laboratory has continued to make progress in the design of electron-optical systems, in the study of structure-function relationships of large multi-subunit proteins, in the development of new image processing software and in achieving a workable sub-angstrom STEM. We present an algebraic approach to the symmetrical Einzel (unipotential) lens wherein we simplify the analysis by specifying a field shape that meets some preferred set of boundary or other conditions and then calculate the fields. In a second study we generalize this approach to study of three element electrostatic lenses of which the symmetrical Einzel lens is a particular form. The purpose is to develop a method for assisting in the design of a lens for a particular purpose. In our biological work we study a stable and functional dodecameric complex of globin chains from the hemoglobin of Lumbricus terrestris. This is a complex lacking the linker'' subunit first imaged in this lab and required for maintenance of the native structure. In addition, we do a complete work-up on the hemoglobin of the marine polychaete Eudistylia vancouverii demonstrating the presence of a hierarchy of globin complexes. We demonstrate stable field-emission in the sub-angstrom STEM and the preliminary alignment of the beam. We continue our exploration of a algorithms for alignment of sequences of protein and DNA. Our computer facilities now include four second generation RISC workstations and we continue to take increasing advantage of the floating-point and graphical performance of these devices.

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

    Science.gov (United States)

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

    2018-06-15

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

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

    Science.gov (United States)

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

    2016-05-01

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

  3. Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.

    Science.gov (United States)

    Refalo, Nathaniel; Chetcuti, Daniel; Tanti, Amy; Serracino-Inglott, Anthony; Borg, John Joseph

    2017-02-01

    The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier. We therefore investigated whether different approaches in various products assessed by the European Medicines Agency during the approval phase resulted in a reduction in resources required to show bioequivalence for different medicinal products. European Public Assessment Reports (EPARs) for off-patent medicinal products authorised within the European Union (EU) through the centralised procedure during the period 2007-2015 were retrieved and reviewed to identify the clinical studies that resulted in fewer number of subjects, the number of centres or trial duration versus the two-period crossover design. 7 studies out of 108 were considered as having benefitted from having a different design. Differences noted included having a different dose allocation scheme, having a different number of dosing periods, having a different number of treatment arms, and having one study evaluating different strengths. Benefits noted included a decrease in the number of subjects and centres required, decreases in study duration and a reduced number of studies required to demonstrate bioequivalence. Bioequivalence studies can be designed in a specific manner to require fewer resources to carry out. Fewer resources required to register a medicinal product, could impart an advantage to companies (such as to be first on the market) or could even translate to making medicines more accessible (such as cheaper) to patients.

  4. Bioequivalence: The Regulatory Career of a Pharmaceutical Concept

    OpenAIRE

    Carpenter, Daniel Paul; Tobbell, Dominique A.

    2011-01-01

    Generic drugs cannot be marketed without regulatory and clinical demonstration of "bioequivalence." The authors argue that the concept of "bioequivalence" is a joint regulatory and scientific creation, not purely a technical concept, and not purely a legal concept. It developed at the interstices of networks of pharmacologists, regulators, food and drug lawyers, and American and European policy makers interested in "generic" drugs. This article provides a situated perspective on the history o...

  5. Social Studies by Electronic Mail.

    Science.gov (United States)

    Barr, Hugh

    1994-01-01

    Asserts that electronic mail provides opportunities to engage students actively in cross-cultural contact with students in other nations. Discusses advantages and problems with using electronic mail in the social studies classroom. Describes electronic mail projects that link students in New Zealand, England, and the United States. (CFR)

  6. Electron Device Contact Studies.

    Science.gov (United States)

    1980-08-01

    including foreign nations. This technical report has been reviewed and is approved for publication. MILLARD C. # IyR , PrFoject Engineer Electronic...potential ED - Ec = TD = donor potential (for Sn in GaAs nD = 5.82 meV [351 Given values for Cs and T, the computer programs find the simultaneous

  7. Molecular studies by electron spectroscopy

    International Nuclear Information System (INIS)

    Hansteen, J.M.

    1977-01-01

    Experience gained in experimental nuclear physics has played a large role in the development of electron spectroscopy as a powerful tool for studying chemical systems. The use of ESCA (Electron Spectroscopy for Chemical Analysis) for the mapping of molecular properties connected with inner as well as outer electron shells is reviewed, mainly from a phenomological point of view. Molecular Auger electron spectroscopy is described as a means of gaining information on details in molecular structure, simultaneously being extensively applied for surface studies. Future highly promising research areas for molecular electron spectroscopy are suggested to be (e,2e) processes as well as continued exploitation of synchrotron radiation from high energy nuclear devices. (Auth.)

  8. From drug delivery systems to drug release, dissolution, IVIVC, BCS, BDDCS, bioequivalence and biowaivers.

    Science.gov (United States)

    Karalis, Vangelis; Magklara, Eleni; Shah, Vinod P; Macheras, Panos

    2010-09-01

    This is a summary report of the conference on drug absorption and bioequivalence issues held in Titania Hotel in Athens (Greece) from the 28(th) to the 30(th) of May 2009. The conference included presentations which were mainly divided into three sections. The first section focused on modern drug delivery systems such as polymer nanotechnology, cell immobilization techniques to deliver drugs into the brain, nanosized liposomes used in drug eluting stents, encapsulation of drug implants in biocompatible polymers, and application of differential scanning calorimetry as a tool to study liposomal stability. The importance of drug release and dissolution were also discussed by placing special emphasis on camptothecins and oral prolonged release formulations. The complexity of the luminal environment and the value of dissolution in lyophilized products were also highlighted. The second session of the conference included presentations on the Biopharmaceutics Classification Scheme (BCS), the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the role of transporters in the classification of drugs. The current status of biowaivers and a modern view on non-linear in vitro-in vivo (IVIVC) correlations were also addressed. Finally, this section ended with a special topic on biorelevant dissolution media and methods. The third day of the conference was dedicated to bioequivalence. Emphasis was placed on high within-subject variability and its impact on study design. Two unresolved issues of bioequivalence were also discussed: the use of generic antiepileptic drugs and the role of metabolites in bioequivalence assessment. Finally, the conference closed with a presentation of the current regulatory status of WHO and EMEA.

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

    Science.gov (United States)

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

    2013-06-01

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

  10. Electron microscope studies

    Energy Technology Data Exchange (ETDEWEB)

    Crewe, A.V.; Kapp, O.H.

    1992-07-01

    This is a report covering the research performed in the Crewe laboratory between 1964 and 1992. Because of limitations of space we have provided relatively brief summaries of the major research directions of the facility during these years. A complete bibliography has been included and we have referenced groups of pertinent publications at the beginning of each section. This report summarizes our efforts to develop better electron microscopes and chronicles many of the experimental programs, in materials science and biology, that acted both as a stimulus to better microscope design and also as a testing ground for many instrumental innovations.

  11. Electron microscope studies

    International Nuclear Information System (INIS)

    Crewe, A.V.; Kapp, O.H.

    1992-01-01

    This is a report covering the research performed in the Crewe laboratory between 1964 and 1992. Because of limitations of space we have provided relatively brief summaries of the major research directions of the facility during these years. A complete bibliography has been included and we have referenced groups of pertinent publications at the beginning of each section. This report summarizes our efforts to develop better electron microscopes and chronicles many of the experimental programs, in materials science and biology, that acted both as a stimulus to better microscope design and also as a testing ground for many instrumental innovations

  12. 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....

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

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

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

  14. Metanálise de estudos de bioequivalência: a intercambiabilidade de genéricos e similares que contêm Hidroclorotiazida é possível, mas não àqueles com Maleato de Enalapril Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate

    Directory of Open Access Journals (Sweden)

    Renato Almeida Lopes

    2010-06-01

    -name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequivalence. To evaluate the safety interchangeability between different generic and similar drugs with Hydrochlorothiazide and Enalapril Maleate, a meta-analysis was carried out with several bioequivalence studies with these drugs. METHODS: Data from bioequivalence of generic and similar drugs approved by the National Health Surveillance Agency (Anvisa (drug regulatory agency in Brazil were used. The compatibility of data from each study was analyzed and the determination of a confidence interval for the differences between the means of pharmacokinetic parameters, area under the curve (ASC0-t and maximum plasma concentration (Cmax, was made for each study by meta-analysis. RESULTS: The interchangeability between the combinations of the three products with Hydrochlorothiazide was confirmed based on the obtained confidence intervals. For the drugs studied with Enalapril Maleate interchangeability has not been confirmed for 50% of the product comparisons. CONCLUSION: The exchange was established between the three products with hydrochlorothiazide. However, for the Enalapril Maleate half of the products studied are not interchangeable, considering they do not match the established intervals for bioequivalence tests, so the pharmacokinetics behavior and thus the effectiveness of the product may be changed.

  15. 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

  16. 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....

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

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

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

  18. 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....

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  20. Bio-equivalent doses of recombinant HCG and recombinant LH during ovarian stimulation result in similar oestradiol output: a randomized controlled study.

    Science.gov (United States)

    Alsbjerg, Birgit; Elbaek, Helle Olesen; Laursen, Rita Jakubcionyte; Povlsen, Betina Boel; Haahr, Thor; Yding Andersen, Claus; Humaidan, Peter

    2017-08-01

    In nature, HCG is secreted by the implanting embryo from peri-implantation and onwards. In contrast, LH is mandatory for steroidogenesis and follicular development during the follicular phase, working in synergy with FSH. Moreover, LH is mandatory for the function of the corpus luteum. Although LH and HCG bind to the same receptor, significant molecular, structural and functional differences exist, inducing differences in bioactivity. This randomized controlled study compared the effect of recombinant FSH stimulation combined with daily either micro-dose recombinant HCG or recombinant LH supplementation in a 1:1 bioactivity ratio from day 1 of stimulation in a long gonadotrophin releasing hormone agonist down regulation protocol. A total of 100 patients from a public clinic completed the study. The primary end-point was the oestradiol level on the day of ovulation trigger and the median oestradiol level in the HCG supplemented group was 8662 pmol/l versus 9203 pmol/l in the recombinant LH supplemented group; therefore, no significant difference was found. Moreover, no differences were observed in the number of oocytes retrieved or in the live birth rate. We conclude that recombinant HCG and recombinant LH are equally effective in boosting oestradiol synthesis during ovarian stimulation when used in a 1:1 bioactivity ratio. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  1. Electron beam diagnostics study

    International Nuclear Information System (INIS)

    Garganne, P.

    1989-08-01

    This paper summarizes the results of a study on beam diagnostics, using carbon wire scanners and optical transition radiation (DTR) monitors. The main consideration consists in the material selection, taking their thermal properties and their effect on the beam into account [fr

  2. Blinded sample size re-estimation in crossover bioequivalence trials.

    Science.gov (United States)

    Golkowski, Daniel; Friede, Tim; Kieser, Meinhard

    2014-01-01

    In drug development, bioequivalence studies are used to indirectly demonstrate clinical equivalence of a test formulation and a reference formulation of a specific drug by establishing their equivalence in bioavailability. These studies are typically run as crossover studies. In the planning phase of such trials, investigators and sponsors are often faced with a high variability in the coefficients of variation of the typical pharmacokinetic endpoints such as the area under the concentration curve or the maximum plasma concentration. Adaptive designs have recently been considered to deal with this uncertainty by adjusting the sample size based on the accumulating data. Because regulators generally favor sample size re-estimation procedures that maintain the blinding of the treatment allocations throughout the trial, we propose in this paper a blinded sample size re-estimation strategy and investigate its error rates. We show that the procedure, although blinded, can lead to some inflation of the type I error rate. In the context of an example, we demonstrate how this inflation of the significance level can be adjusted for to achieve control of the type I error rate at a pre-specified level. Furthermore, some refinements of the re-estimation procedure are proposed to improve the power properties, in particular in scenarios with small sample sizes. Copyright © 2014 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

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

    2007-06-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    KAUST Repository

    Al-Talla, Zeyad

    2011-01-01

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

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

    Science.gov (United States)

    Al-Talla, Z A; Akrawi, S H; Emwas, A-H M

    2011-07-01

    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. 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 AUC(0-∞), AUC(0-t), C(max), K(e), 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. 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. 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.

  7. When Bioequivalence in Healthy Volunteers May not Translate to Bioequivalence in Patients: Differential Effects of Increased Gastric pH on the Pharmacokinetics of Levothyroxine Capsules and Tablets.

    Science.gov (United States)

    Seng Yue, Corinne; Benvenga, Salvatore; Scarsi, Claudia; Loprete, Luca; Ducharme, Murray P

    2015-01-01

    Clinical studies have suggested that proton pump inhibitors may decrease levothyroxine absorption and an in vitro study suggested that the effect of pH on dissolution may differ with formulation. To determine the impact of formulation on the pharmacokinetics of levothyroxine in altered gastric pH conditions, this study compared the pharmacokinetics of levothyroxine capsules and tablets, two formulations deemed bioequivalent in healthy volunteers under fasting conditions, when taken with or without esomeprazole. Two clinical studies were conducted in healthy volunteers given single dose levothyroxine (600 mg) with a 45-day washout period. In Study 1 (parallel-design/two-way crossover), 16 subjects received either levothyroxine capsules or tablets, each group with or without prior administration of intravenous esomeprazole (maximum dose of 80 mg). In Study 2 (two-way crossover), 16 subjects received both capsules or tablets after intravenous esomeprazole. Blood samples were collected pre-dose and up to 24 hours post-dose. Baseline-adjusted pharmacokinetic parameters were calculated: Cmax (maximal concentration), Tmax (time to Cmax), AUC0-t (area under the concentration-time curve from 0 to the last detectable concentration), AUC0-6 and AUC0-12 (areas under the curve from 0 to 6 and 12 hours, respectively). Analyses of variance were conducted to compare ln-transformed Cmax and AUC. Non-parametric Tmax analyses were done. In Study 1, esomeprazole caused a greater decrease in overall levothyroxine exposure of tablets vs. capsules (13% vs 6% for Cmax, 18% vs. 14% for AUC(0-6), 17% vs. 5% for AUC(0-12) and 10% vs. 8% for AUC(0-t)). In Study 2 esomeprazole administration resulted in a 16% smaller levothyroxine exposure with tablets vs. capsules. No statistically significant differences in Tmax were found. Although both formulations are considered "bioequivalent" in healthy volunteers, they may not necessarily be bioequivalent in patients with impaired gastric pH conditions

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

    Directory of Open Access Journals (Sweden)

    "Tajerzadeh H

    2001-07-01

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

  9. Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.

    Science.gov (United States)

    Polli, James E; Abrahamsson, Bertil S I; Yu, Lawrence X; Amidon, Gordon L; Baldoni, John M; Cook, Jack A; Fackler, Paul; Hartauer, Kerry; Johnston, Gordon; Krill, Steve L; Lipper, Robert A; Malick, Waseem A; Shah, Vinod P; Sun, Duxin; Winkle, Helen N; Wu, Yunhui; Zhang, Hua

    2008-06-01

    The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

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

    OpenAIRE

    "Tajerzadeh H; Hamidi M; Rouini MR; Shahverdi M; Ghaiumi A "

    2001-01-01

    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 ...

  11. Bioequivalence evaluation of two brands of aceclofenac 100 mg tablets (Aceclofar and Bristaflam) in healthy human volunteers.

    Science.gov (United States)

    Najib, Naji; Idkaidek, Nasir; Beshtawi, M; Bader, Mohammed; Admour, Isra'; Alam, S Mahmood; Zaman, Q; Dham, Ruwayda

    2004-04-01

    A randomized, two-way, crossover, bioequivalence study in 24 fasting, healthy, male volunteers was conducted to compare two brands of aceclofenac 100 mg tablets, Aceclofar (Julphar, UAE) as test and Bristaflam (Bristol Myers Squibb, Egypt) as the reference product. The drug was administered with 240 ml of water after a 10 h overnight fast on two treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 24 h. Plasma harvested from blood was analysed for aceclofenac by a validated HPLC method with UV-visible detection capable of detecting aceclofenac in the range 0.2-8.0 microg/ml with the limit of quantitation as 0.2 microg/ml. Various pharmacokinetic parameters including AUC(0-t), AUC(0- infinity ), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0- infinity), and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (100.0%-106.4% for AUC(0-t), 100.2%-106.8% for AUC(0- infinity ); 83.3%-102.8% for C(max)) of test/reference ratio for these parameters were found to be within the bioequivalence acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Aceclofar is bioequivalent to Bristaflam. Copyright 2004 John Wiley & Sons, Ltd.

  12. Bioequivalence assessment of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK)--Two brands of Acyclovir--in healthy human volunteers.

    Science.gov (United States)

    Najib, Naji M; Idkaidek, Nasir; Beshtawi, Muntaser; Mohammed, B; Admour, Isra'; Alam, S Mahmood; Dham, Ruwayda

    2005-01-01

    Two studies were performed to assess the relative bioavailability of Lovrak (Julphar, UAE) compared with Zovirax (Glaxo Wellcome, UK) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved acyclovir tablets and the other acyclovir suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of acyclovir were administered as a single dose on 2 treatment days separated by 1 week washout period. After dosing, serial blood samples were collected for a period of 16 h. Plasma harvested from blood, was analysed for acyclovir by an HPLC method with UV detection. Various pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2 and Kelm were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC0-t, AUC(0-proportional to), and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratio of these parameters were found within the bioequivalence acceptance range 80%-125%. Based on these statistical inferences it was concluded that a Lovrak tablet is bioequivalent to a Zovirax tablet and that Lovrak suspension is bioequivalent to Zovirax suspension. 2004 John Wiley & Sons, Ltd.

  13. Evaluation of statistical power function for various diclofenac bioequivalence trials with different subject numbers.

    Science.gov (United States)

    Popović, Jovan; Mikov, Momir; Sabo, Ana; Jakovljević, Vida

    2009-01-01

    This study presents application of statistical power function for the t-test and ANOVA F-test on the evaluation of diclofenac bioequivalence in trials with the wide variations in sample sizes (N = 12, 18 and 24). The power function, together with appropriate equations tables and figures, is used to calculate the power of the ANOVA for crossover design, the number of subjects for a given value of power and the minimum detectable difference in treatment means for different pharmacokinetic parameters of the formulations. The power of the trial with a small, sample size (N = 12) to detect 20% differences between diclofenac formulations is shown to be more than 0.9 and almost the same as the power of the trial with a large sample size (N = 24). In all trials for all pharmacokinetic parameters the power to detect 20% difference is shown to be more than 0.8. For the power of 0.8, the needed subject number to detect 20% difference in treatment means is the same or smaller than used and the minimum detectable difference is smaller than 20% in all our trials. This investigation shows that bioequivalence studies with small number of subjects (N = 12) may be quite adequate for valid conclusions.

  14. Bioequivalence evaluation of two brands of fluoxetine 20 mg capsules (Flutin and Prozac) in healthy human volunteers.

    Science.gov (United States)

    Najib, Naji M; Idkaidek, Nasir; Beshtawi, Muntaser; Mohammed, B; Admour, Isra; Alam, S Mahmood; Dham, Ruwayda; Qumaruzaman

    2005-09-01

    A bioequivalence study of two oral formulations of 20 mg fluoxetine was carried out in 24 healthy volunteers following a single dose, two-sequence, crossover randomized design at International Pharmaceutical Research Centre (IPRC), Amman, Jordan. The two formulations were Flutin capsules (Julphar, UAE) as test and Prozac capsules (Eli Lilly, UK) as reference product. Test and reference capsules were administered to each subject after an overnight fasting on two treatment days separated by a 28 day washout period. After dosing, serial blood samples were collected for a period of 360 h. Plasma harvested from blood was analysed for fluoxetine by a sensitive, reproducible and accurate LC-MS method. Various pharmacokinetic parameters including AUC(0-t), AUC(0-infinity), C(max), T(max), T(1/2), and lambda(Z) were determined from plasma concentrations for both formulations and found to be in good agreement with reported values. AUC(0-t), AUC(0-infinity) and C(max) were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval (94.60%-106.41% for AUC(0-t), 94.6%-108.14% for AUC(0-infinity); 91.88%-103.65% for C(max)) for test/reference ratio of these parameters were found within FDA acceptance range of 80%-125%. Based on these statistical inferences, it was concluded that Flutin is bioequivalent to Prozac and can be used interchangeably in medical practice. Copyright 2005 John Wiley & Sons, Ltd

  15. Electron Cooling Study for MEIC

    International Nuclear Information System (INIS)

    Electron cooling of the ion beams is one critical R&D to achieve high luminosities in JLab's MEIC proposal. In the present MEIC design, a multi-staged cooling scheme is adapted, which includes DC electron cooling in the booster ring and bunched beam electron cooling in the collider ring at both the injection energy and the collision energy. We explored the feasibility of using both magnetized and non-magnetized electron beam for cooling, and concluded that a magnetized electron beam is necessary. Electron cooling simulation results for the newly updated MEIC design is also presented.

  16. Percutaneous penetration of methyl nicotinate from ointments using the laser Doppler technique: bioequivalence and enhancer effects.

    Science.gov (United States)

    Remane, Yvonne; Leopold, Claudia S; Maibach, Howard I

    2006-12-01

    Laser Doppler flowmetry (LDF) may be used to quantify erythema response as a result of an increased cutaneous microcirculation induced by methyl nicotinate (MN). Bioequivalence of a test and a standard preparation (vehicles: light mineral oil and medium chain triglycerides, respectively) was confirmed according to the pilot study of the FDA Guidance for Industry "Topical dermatologic corticosteroids: In Vivo bioequivalence" applying the staggered application and synchronized removal method for one defined concentration. Furthermore, the influence of penetration enhancers (5% w/w Dimethylsulfoxide (DMSO) and 10% w/w diethylene glycol monoethyl ether) on MN penetration was investigated. It was shown that DMSO and diethylene glycol monoethyl ether altered cutaneous microcirculation and thus MN penetration in comparison to the standard formulation. However, true penetration enhancement could only be proved with diethylene glycol monoethyl ether resulting from an improved drug solubility in the skin which was confirmed by attenuated total reflectance fourier transform infrared spectroscopy (ATR-FTIR). Increased MN penetration by DMSO was only caused by thermodynamic effects, i.e. a decreased drug solubility in the vehicle.

  17. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

    Science.gov (United States)

    Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee

    2017-08-01

    This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche). Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early. The primary end point was area under the concentration-time curve (AUC) of the analyte in plasma from time zero extrapolated to infinity (AUC 0-∞ ). Other pharmacokinetic (PK) parameters, safety, and in vitro binding affinity were also evaluated. The interim analysis demonstrated three-way bioequivalence for all comparisons. The confidence intervals around the geometric mean ratios of the primary and secondary PK parameters were within the predefined acceptance ranges. Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087.

  18. Feasibility study for mega-electron-volt electron beam tomography.

    Science.gov (United States)

    Hampel, U; Bärtling, Y; Hoppe, D; Kuksanov, N; Fadeev, S; Salimov, R

    2012-09-01

    Electron beam tomography is a promising imaging modality for the study of fast technical processes. But for many technical objects of interest x rays of several hundreds of keV energy are required to achieve sufficient material penetration. In this article we report on a feasibility study for fast electron beam computed tomography with a 1 MeV electron beam. The experimental setup comprises an electrostatic accelerator with beam optics, transmission target, and a single x-ray detector. We employed an inverse fan-beam tomography approach with radiographic projections being generated from the linearly moving x-ray source. Angular projections were obtained by rotating the object.

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

    Science.gov (United States)

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

    2002-11-07

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

  20. Electronic study books and learning style

    NARCIS (Netherlands)

    de Diana, I.P.F.; van der Heiden, G.

    1994-01-01

    Attention has been drawn to the concepts of Electronic Books and Electronic Study Books. Several publications have discussed some main ideas (paradigms) for both concepts. For the Electronic Study Book as a learning environment, it is essential to consider individual modes of learning, usually

  1. Bioequivalence study of four different trademarks of enalapril maleate in spontaneously hypertensive rats Estudo da bioequivalência de quatro diferentes marcas comerciais de maleato de enalapril em ratos espontaneamente hipertensos

    Directory of Open Access Journals (Sweden)

    Nilo César do Vale Baracho

    2008-04-01

    Full Text Available INTRODUCTION: High blood pressure is a systemic disease which has major clinical and psycho-social repercussions, involves a high morbidity-mortality rate and generates high costs for the health system. Its treatment involves the use of antihypertensive drugs, which are commercialized as trademark, generic or similar drugs. PURPOSE: To verify the antihypertensive effect produced by a similar dose of different trademarks of enalapril maleate in spontaneously hypertensive rats (SHR. METHODS: Fifteen mg/kg of enalapril maleate were administered by gavage in 50 SHR rats and their blood pressure was verified through tail plethysmography every three days in a period of 16 days. RESULTS: The group treated with reference drug has shown a significant reduction on blood pressure levels when compared to the control group. Thus, treatments with enalapril maleate of generic, similar-A and similar-B brands have also shown significant reduction on animals' blood pressure. CONCLUSION: The use of generic drug and similars (A and B drugs in the same doses and for the same period of time has not shown significant difference regarding the reference drug, which suggests that the brands tested are bioequivalent.INTRODUÇÃO: A hipertensão arterial é uma doença sistêmica que traz grandes repercussões clínicas e psico-sociais, cursa com uma elevada morbi-mortalidade e gera elevados gastos para o sistema de saúde. Seu tratamento envolve a utilização de fármacos anti-hipertensivos, os quais são comercializados como remédios de marca, genéricos ou similares. PURPOSE: Verificar o efeito anti-hipertensivo produzido por dose igualitária de diferentes marcas de maleato de enalapril, em ratos naturalmente hipertensos. MÉTODOS: Foram administrados, por meio de gavagem, 15 mg/kg de maleato de enalapril em 50 ratos naturalmente hipertensos e verificada a pressão arterial, através de pletismografia de cauda, a cada três dias, em um período de 16 dias. RESULTADOS

  2. [Pharmacokinetics and bioequivalence of atorvastatin calcium tablets in healthy male Chinese volunteers].

    Science.gov (United States)

    Shen, Yi; Zhang, Yi-fan; Chen, Xiao-yan; Guo, Li-xia; Zhong, Da-fang

    2012-03-01

    To compare the bioequivalence and pharmacokinetics of national made and imported atorvastatin in healthy male Chinese volunteers after single oral administration. This randomized sequence, open-label, two-period crossover study with a one-week washout period between doses was performed in 24 fasting healthy Chinese males. They were randomly assigned to receive 20 mg of either the test (national made) or reference (imported) formulation orally. The blood samples were collected over a 72-hour period. Plasma concentrations of parent atorvastatin (AT), ortho-hydroxy-atorvastatin (o-OAT) and para-hydroxy-atorvastatin (p-OAT) were simultaneously determined using the validated liquid chromatography-tandem mass spectrometry method, the bioequivalence was also evaluated throughout the study. The main pharmacokinetic parameters of test and reference formulations were as follows: the values of C(max) for AT were (10.6 ± 11.9) µg/L and (10.6 ± 9.8) µg/L, t(1/2z) were (11.4 ± 3.9) h and (11.4 ± 5.3) h, AUC(0-t) were (54.2 ± 37.4) µg×h(-1)×L(-1) and (51.7 ± 34.1) µg×h(-1)×L(-1), respectively. The values of C(max) for o-OAT were (7.8 ± 4.5) µg/L and (7.6 ± 4.3) µg/L, t(1/2z) were (12.3 ± 4.2) h and (11.9 ± 3.4) h, AUC(0-t) were (96.8 ± 48.2) µg×h(-1)×L(-1) and (92.3 ± 44.4) µg×h(-1)×L(-1), respectively. The values of C(max) for p-OAT were (0.5 ± 0.4) µg/L and (0.4 ± 0.3) µg/L, t(1/2z) were (18.4 ± 12.4) h and (23.3 ± 17.8) h, AUC(0-t) were (15.9 ± 12.3) µg×h(-1)×L(-1) and (13.8 ± 8.11) µg×h(-1)×L(-1), respectively. The relative bioavailability of AT and o-OAT in test formulation were (105.3 ± 20.7)% and (107.8 ± 23.2)%, respectively. The 90% confidence interval of the test/reference geometric mean ratios of AUC(0-t) for AT and o-OAT were (97.7 - 110.5)% and (98.3 - 111.3)%, C(max) for AT and o-OAT were (75.8 - 114.0)% and (90.6 - 122.9)%, they were all located within the bioequivalence criteria range (80% - 125% for AUC, and 70% - 143

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

    Science.gov (United States)

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

    2018-04-12

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

  4. Bioequivalence and adhesion evaluation of transdermal clonidine following a change in excipient supplier.

    Science.gov (United States)

    Ehrlich, Jerome; Beck, Bonnie; Thiedmann, Ralf; Marzin, Kristell; MacGregor, Thomas

    2016-10-01

    To evaluate the bioequivalence (BE), safety, tolerability, and adhesion of Oppanol® polyisobutylene (PIB)-containing transdermal therapeutic system (TTS) formulation (test treatment, T) with VistanexTM PIB-containing TTS formulation (reference treatment, R) of clonidine. This randomized, double-blind, 2-way crossover study comprised a 7-day treatment with 0.3 mg clonidine/24 h (T1/R1), a 7-day washout, and another 7-day treatment (R1/T1) period. After a 3-day washout period, subjects used T2 and R2 (each 0.1 mg clonidine/24 h) simultaneously in the 7-day adhesion phase. Primary endpoints were AUC0-168 and Cavg. Secondary endpoints were AUC0-∞ and Cmax. Additional endpoints included adhesion properties for all phases. For the primary endpoint, the geometric mean (gMean) ratios for test/reference treatment were calculated with BE defined as 90% confidence interval (CI) between 80 and 125%. 58 subjects (mean age, 41.3 years) received treatment (T1/R1, n = 29; R1/T1, n = 29); 55 completed the adhesion phase. BE criteria were met for the primary and secondary endpoints. Adjusted gMean ratios for T1/R1 were 102.3% (90% CI: 95.7%, 109.4%) for AUC0-168; 104.3% (90% CI: 98.4%, 110.5%) for Cavg; 102.8% (90% CI: 97.3%, 108.6%) for AUC0-∞; and 104.0% (90% CI: 98.2%, 110.3%) for Cmax. Mean adhesion was greater than 90% for all four patch types when data from all assessment times were included. Most frequently reported adverse events were general disorders and local irritation. Clonidine Oppanol® PIB-containing TTS formulation was bioequivalent to VistanexTM PIB-containing TTS formulation and had similar adhesive properties. Both doses and formulations of clonidine-TTS were well tolerated.

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

    Science.gov (United States)

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability... drug products containing the following active ingredients: A Acetaminophen; Caffeine; Dihydrocodeine...

  6. Steady state bioequivalence of generic and innovator formulations of stavudine, lamivudine, and nevirapine in HIV-infected Ugandan adults.

    Directory of Open Access Journals (Sweden)

    Jayne Byakika-Tusiime

    Full Text Available Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune or the corresponding brand formulations (Epivir, Zerit, and Viramune.An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received lamivudine (150 mg, stavudine (40 mg, and nevirapine (200 mg in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC(0-12h and C(max. Bioequivalence was defined as a geometric mean ratio between the generic and brand name within the 90% confidence interval of 0.8-1.25. The geometric mean ratios and the 90% confidence intervals were: stavudine C(max, 1.3 (0.99-1.71 and AUC(0-12h, 1.1 (0.87-1.38; lamivudine C(max, 0.8 (0.63-0.98 and AUC(0-12h, 0.8 (0.65-0.99; and nevirapine C(max, 1.1 (0.95-1.23 and AUC(0-12h, 1.1 (0.95-1.31. The generic formulation was not statistically bioequivalent to the brand formulations during steady state, although exposures were comparable. A mixed random effects model identified about 50% intersubject variability in the pharmacokinetic parameters.These findings provide support for the use of Triomune in resource-limited settings, although identification of the sources of intersubject variability in these populations is critical.

  7. Card - Electronic Money. Comparative Study

    Directory of Open Access Journals (Sweden)

    Mariana Rodica TIRLEA

    2012-11-01

    Full Text Available This type of coin and appeared as a result of the needs for a proper management of the financial resources available in the market, but also to improve the payments system in our country. The card is an alternative to the conventional instruments of payment is a payment instrument with and without cash by means of which the holder disposes of the current account. It is a standardized, secure information and individualized, through which you can perform operations of cash withdrawal, payment for the goods or services purchased, payment obligations by the public administration authorities and funds transfers between accounts, other than those ordered and executed by financial institutions, carried out through the electronic payment instrument.

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

    Science.gov (United States)

    Pai, Amy Barton

    2017-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Gloria Holguín Martínez

    2001-01-01

    Full Text Available 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 respecto a AUC, pero no lo son con respecto a Cmáx y tmáx. 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

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

    Science.gov (United States)

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

    2015-06-01

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

  11. Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 microg and fluticasone propionate 250 microg: implications for establishing bioequivalence of inhaled products.

    Science.gov (United States)

    Daley-Yates, Peter T; Parkins, David A; Thomas, Marian J; Gillett, Benjamin; House, Karen W; Ortega, Hector G

    2009-02-01

    The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of the treatment. This study was designed to compare the pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety data for 2 DPIs delivering a combination of salmeterol 50 microg plus fluticasone propionate (FP) 250 microg (SFC 50/250) to investigate assumptions of bioequivalence. Three studies compared SFC 50/250 delivery using a reservoir powder inhalation device (RPID) and a Diskus multiple-dose inhaler: an in vitro assessment of fine-particle-mass (FPM) profiles of the emitted doses; a PK/PD study of SFC 50/250 administered in two 14-day crossover treatment periods to 22 adults with moderate, persistent asthma to determine the equivalence of the RPID and Diskus inhaler in terms of drug delivery and systemic exposure; and a 12-week clinical efficacy and safety study of SFC 50/250 in 270 patients > or =12 years of age with moderate, persistent asthma to assess the equivalence of the RPID and Diskus inhaler based on peak expiratory flow (PEF) rates. FPM was summed from the quantity of active pharmaceutical ingredient deposited on stages 1 to 5 of a cascade impactor, representing an aerodynamic particle size range of 0.8 to 6.2 microm. Systemic exposure to SFC 50/250 was declared no greater with RPID than with the Diskus inhaler if the upper limit of the 90% CI for the ratio of FP AUC for the 2 devices was below the upper limit of the equivalence range (ie, <1.25). Adverse events, clinical laboratory test results, and vital signs were recorded throughout the 2 clinical studies. In vitro, mean FPM values for the RPID and Diskus inhaler, respectively, were 13.1 and 12.8 microg/dose for salmeterol (P = NS) and 66.8 and 66.2 microg/dose for FP (P = NS). The

  12. 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

  13. Electron impact study of potassium hydroxide

    International Nuclear Information System (INIS)

    Vuskovic, L.; Trajmar, S.

    1979-01-01

    An ''elastic'' scattering study for low impact energies (5--20 ev) is reported for electron impact excitation of KOH. The ''elastic'' scattering is regarded as the sum of elastic rotational and vibrational contributions to the scattering

  14. NATO Advanced Study Institute on Electron Crystallography

    CERN Document Server

    Weirich, Thomas E; Zou, Xiaodong

    2006-01-01

    During the last decade we have been witness to several exciting achievements in electron crystallography. This includes structural and charge density studies on organic molecules complicated inorganic and metallic materials in the amorphous, nano-, meso- and quasi-crystalline state and also development of new software, tailor-made for the special needs of electron crystallography. Moreover, these developments have been accompanied by a now available new generation of computer controlled electron microscopes equipped with high-coherent field-emission sources, cryo-specimen holders, ultra-fast CCD cameras, imaging plates, energy filters and even correctors for electron optical distortions. Thus, a fast and semi-automatic data acquisition from small sample areas, similar to what we today know from imaging plates diffraction systems in X-ray crystallography, can be envisioned for the very near future. This progress clearly shows that the contribution of electron crystallography is quite unique, as it enables to r...

  15. Theoretical study of free electron laser physics

    Energy Technology Data Exchange (ETDEWEB)

    Yoo, Jae Gwon; Cho, Sung Oh; Jeong, Young Uk; Kim, Sun Kook; Lee, Byung Cheol; Cha, Byung Heon; Lee, Jong Min [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2000-04-01

    A theoretical study of free electron laser physics is presented in this report. In particular, an analysis is given of the free electron laser with a linearly polarized magnetic wiggler. We describe the basic electron dynamics and gain mechanism in a free electron laser by solving the one-body classical Lorentz force equations in the presence of a periodic magnetic field and a plane electromagnetic wave. Phase space paths for electrons analogously related to those of a simple pendulum are used to describe the laser gain and saturation, and the evolution of the electron beam energy and position distributions. We present an analysis of the single-mode problem and a self-consistent nonlinear treatment of the finite transverse dimensional effects associated with the free electron laser in a steady state. Results computed by applying an external D.C. electric field to the system are discussed for investigating efficiency enhancement of the free electron lasers. Finally optical guiding effect in small signal regime is described to investigate the possibility of amplifying radiation fields in very long wigglers for large gain and high extraction efficiency. 14 refs., 45 figs. (Author)

  16. Demonstrating comparative in vitro bioequivalence for animal drug products through chemistry and manufacturing controls and physicochemical characterization: a proposal.

    Science.gov (United States)

    Martinez, Marilyn N; Fahmy, Raafat

    2015-03-01

    The assessment of in vivo bioequivalence (BE) of nonsystemically absorbed drug products has been a longstanding challenge facing drug manufacturers and regulators of human or animal health products. Typically, in situations where blood level BE studies are not feasible, clinical endpoint BE trials have provided the only option for generating interproduct comparisons. Given the imprecision and logistic challenges associated with these studies, there has been an effort to identify alternative pathways that can reliably ensure the equivalence of product performance and quality. This commentary provides a proposal for an in vitro approach for evaluating the in vivo BE of veterinary drug products that are either nonsystemically absorbed or that act both locally and systemically but where the local site of action is proximal to the absorption window. The assumption underlying this approach is that equivalence in product physicochemical attributes and in vitro product performance translates to equivalence in product in vivo behavior. For sponsors with a right of reference to underlying safety and effectiveness data, this approach could be used to support pre and post-approval changes. When comparing a generic test product to the pioneer (reference listed new animal drug, RLNAD) product, a demonstration of sameness across a battery of in vitro test procedures could be used to confirm that the test and RLNAD products are bioequivalent.

  17. In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration.

    Science.gov (United States)

    Ren, Ping; Cui, Minglei; Anand, Om; Xia, Li; Zhao, Zhuojun J; Sun, Dajun; Sharp, Trueman; Conner, Dale P; Peters, John; Jiang, Wenlei; Stier, Ethan; Jiang, Xiaojian

    2017-11-01

    Administration of proton pump inhibitors (PPIs) through nasogastric tubes may present risks. If the PPI drug products are not prepared properly, clogging or obstruction of nasogastric tubes can pose a safety concern. In addition, the integrity of the enteric coating of the drug product may be damaged resulting in reduced bioavailability of the active moiety. From the perspective of administration of generic PPIs when compared to the reference drug product, differences in formulation can potentially result in a greater relative risk for the generic drug product. As part of the assessment of bioequivalence, the Office of Generic Drugs (OGD) has developed a suite of in vitro testing to compare the delivery of the generic and reference products via nasogastric tubes. These in vitro tests assess essential attributes associated with the likelihood of clogging and maintenance of the enteric coating. These in vitro tests include studies evaluating sedimentation, granule size distribution, drug recovery, and acid resistance. One of the challenges is that while the administration of PPIs through nasogastric tubes is common in clinical practice, this issue is not uniformly addressed in the FDA approved label of the reference drug products. This paper discusses the design and rationale for in vitro testing of PPI formulations with respect to bioequivalence via nasogastric tube administration and in addition, it summarizes commonly occurring deficiencies in the in vitro nasogastric tube testing of 14 recent Abbreviated New Drug Applications (ANDA) submitted for five generic PPI drug products.

  18. Bioequivalence of a Liquid Formulation of Alpha1-Proteinase Inhibitor Compared with Prolastin®-C (Lyophilized Alpha1-PI) in Alpha1-Antitrypsin Deficiency.

    Science.gov (United States)

    Barker, Alan F; Campos, Michael A; Brantly, Mark L; Stocks, James M; Sandhaus, Robert A; Lee, Douglas; Steinmann, Kimberly; Lin, Jiang; Sorrells, Susan

    2017-12-01

    This study evaluated the bioequivalence, safety, and immunogenicity of a new liquid formulation of human plasma-derived alpha 1 -proteinase inhibitor, Liquid Alpha 1 -PI, compared with the Lyophilized Alpha 1 -PI formulation (Prolastin®-C), for augmentation therapy in patients with alpha 1 -antitrypsin deficiency (AATD). In this double-blind, randomized, 20-week crossover study, 32 subjects with AATD were randomized to receive 8 weekly infusions of 60 mg/kg of Liquid Alpha 1 -PI or Lyophilized Alpha 1 -PI. Serial blood samples were drawn for 7 days after the last dose followed by 8 weeks of the alternative treatment. The primary endpoint was bioequivalence at steady state, as measured by area under the concentration versus time curve from 0 to 7 days (AUC 0-7 days ) postdose using an antigenic content assay. Bioequivalence was defined as 90% confidence interval (CI) for the ratio of the geometric least squares (LS) mean of AUC 0-7 days for both products within the limits of 0.80 and 1.25. Safety and immunogenicity were assessed. Mean alpha 1 -PI concentration versus time curves for both formulations were superimposable. Mean AUC 0-7 days was 20 320 versus 19 838 mg × h/dl for Liquid Alpha 1 -PI and Lyophilized Alpha 1 -PI, respectively. The LS mean ratio of AUC 0-7 days (90% CI) for Liquid Alpha 1 -PI versus Lyophilized Alpha 1 -PI was 1.05 (1.03-1.08), indicating bioequivalence. Liquid Alpha 1 -PI was well tolerated and adverse events were consistent with Lyophilized Alpha 1 -PI. Immunogenicity to either product was not detected. In conclusion, Liquid Alpha 1 -PI is bioequivalent to Lyophilized Alpha 1 -PI, with a similar safety profile. The liquid formulation would eliminate the need for reconstitution and shorten preparation time for patients receiving augmentation therapy for AATD.

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

    Science.gov (United States)

    Tsume, Yasuhiro; Amidon, Gordon L

    2010-08-02

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

  20. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

    Science.gov (United States)

    Braddy, April C; Davit, Barbara M; Stier, Ethan M; Conner, Dale P

    2015-01-01

    The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international regulatory authorities and organizations. These drug products are locally applied and not intended for systemic absorption. Therefore, the BE approaches which serve as surrogates to establish safety and efficacy for topical dosage forms tend to differ from the traditional solid oral dosage forms. We focused on 15 different international jurisdictions and organizations that currently participate in the International Generic Drug Regulators Pilot Project. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association (EMA), Japan, Mexico, New Zealand, Singapore (a member of the Association of Southeast Asian Nations), South Africa, South Korea, Switzerland, the USA and the World Health Organization (WHO). Upon evaluation, we observed that currently only Canada, the EMA, Japan, and the USA have specific guidance documents for topical drug products. Across all jurisdictions and organizations, the three approaches consistently required are (1) BE studies with clinical endpoints for most topical drug products; (2) in vivo pharmacodynamic studies, in particular the vasoconstrictor assay for topical corticosteroids; and (3) waivers from BE study requirements for topical solutions. Japan, South Africa, the USA, and the WHO are also making strides to accept other BE approaches such as in vivo pharmacokinetic studies for BE assessment, in vivo dermatopharmacokinetic studies and/or BE studies with in vitro endpoints.

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

    Science.gov (United States)

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

    2015-08-01

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

  2. Scanning electron microscopy study of Trichomonas gallinae.

    Science.gov (United States)

    Tasca, Tiana; De Carli, Geraldo A

    2003-12-01

    A scanning electron microscopy (SEM) study of Trichomonas gallinae (Rivolta, 1878), provided more information about the morphology of this flagellated protozoan. SEM showed the morphological features of the trophozoites; the emergence of the anterior flagella, the structure of the undulating membrane, the position and shape of the pelta, axostyle and posterior flagellum. Of special interest were the pseudocyst forms.

  3. THEORETICAL STUDY ON ELECTRONIC STRUCTURES AND ...

    African Journals Online (AJOL)

    THEORETICAL STUDY ON ELECTRONIC STRUCTURES AND SPECTROSCOPY OF TRIARYLBORANE SUBSTITUTED BY THIOPHENE. ... Also, the 13C chemical shifts of the carbon atoms on the phenyl rings in these compounds are upfield relative to those of the same carbon atoms in the parent compound.

  4. Electron cloud buildup studies for the LHC

    CERN Document Server

    AUTHOR|(CDS)2160803; Boine-Frankenheim, Oliver

    Electron clouds can develop in accelerators operating with positively charged particles. The con- sequences of e-cloud related effects are very important for the operation of the Large Hadron Collider (LHC) at CERN, and for the design of future accelerators including the LHC luminosity upgrade (HL-LHC). High electron densities are generated by an interaction between the beam and the confining chamber. Primary electrons, that can be generated through various mecha- nisms, are accelerated by the beam and impinge on the chamber walls, thereby extracting more electrons from the material. Furthermore they also deposit their kinetic energy in the process, which has to be compensated by the cooling system. Especially in cryogenic environments, as it is the case for a large part of the LHC, high heat loads can pose a serious problem. In order to improve the understanding of the electron cloud, simulation studies are performed with the code PyECLOUD, developed at CERN. The work of the first half of the project is desc...

  5. Runaway-electron-materials interaction studies

    International Nuclear Information System (INIS)

    Bolt, H.; Miyahara, A.

    1990-03-01

    During the operation of magnetic fusion devices it has been frequently observed that runaway electrons can cause severe damage to plasma facing components. The energy of the runaway electrons could possibly reach several 100 MeV in a next generation device with an energy content in the plasma in the order of 100 MJ. In this study effects of high energy electron - materials interaction were determined by laboratory experiments using particle beam facilities, i.e. the Electron Linear Accelerator of the Institute of Scientific and Industrial Research of Osaka University and the 10 MW Neutral Beam Injection Test Stand of the National Institute for Fusion Science. The experiments and further analyses lead to a first assessment of the damage thresholds of plasma facing materials and components under runaway electron impact. It was found that metals (stainless steel, molybdenum, tungsten) showed grain growth, crack formation and/or melting already below the threshold for crack initiation on graphite (14-33 MJ/m 2 ). Strong erosion of carbon materials would occur above 100 MJ/m 2 . Damage to metal coolant channels can occur already below an energy deposition of 100 MJ/m 2 . The energy deposited in the metal coolant channels depends on the thickness of the plasma facing carbon material D, with the shielding efficiency S of carbon approximately as S∼D 1.15 . (author) 304 refs. 12 tabs. 59 figs

  6. 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

    of 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...... development, improvement and validation during the last decade and has proved to be a versatile, safe and valuable tool for pharmacokinetic and pharmacodynamic studies. This review gives an overview of the current state and future perspectives of dermal MD sampling. Methodological issues such as choice...... is concluded by the current regulatory point of view. The future perspective includes further expansion and validation of the use of MD in the experimental and clinical setting as well as in the optimization of the method for regulatory purposes, i.e. the commercialization of bioequivalent, generic drug...

  7. Future studies on electron scattering; a renaissance

    International Nuclear Information System (INIS)

    Mason, Nigel J

    2014-01-01

    2014 is the centenary of the first announcement of the Franck-Hertz experiment [1], now regarded as one of the pivotal experiments of modern physics. The Franck-Hertz experiment is widely regarded as an experiment that provided validation of the Bohr theory of atomic structure, itself only published in 2013, however it should also be viewed as the first quantitative experiment in electron scattering and the birth of scientific study of atomic and molecular phenomena by collisions. Today we recognize that electron-atom and electron- molecule collisions are prevalent across nature, describing disparate phenomena whilst the exploitation of such collisions underpins many of the technologies upon which modern society relies. The centenary of the Franck-Hertz experiment is thus a suitable opportunity to review both our current knowledge of electron interactions and to consider the directions of future research. In this article I therefore aim to both review our current state of knowledge and look forward, proposing that recent advances are providing something of a renaissance to the field and are vital for emerging technologies as well as answering some of the greatest scientific challenges of the 21st century

  8. NATO Advanced Study Institute on Superconducting Electronics

    CERN Document Server

    Nisenhoff, Martin; Superconducting Electronics

    1989-01-01

    The genesis of the NATO Advanced Study Institute (ASI) upon which this volume is based, occurred during the summer of 1986 when we came to the realization that there had been significant progress during the early 1980's in the field of superconducting electronics and in applications of this technology. Despite this progress, there was a perception among many engineers and scientists that, with the possible exception of a limited number of esoteric fundamental studies and applications (e.g., the Josephson voltage standard or the SQUID magnetometer), there was no significant future for electronic systems incorporating superconducting elements. One of the major reasons for this perception was the aversion to handling liquid helium or including a closed-cycle helium liquefier. In addition, many critics felt that IBM's cancellation of its superconducting computer project in 1983 was "proof" that superconductors could not possibly compete with semiconductors in high-speed signal processing. From our persp...

  9. A SCANNING ELECTRON MICROSCOPIC STUDY OF HYPERCEMENTOSIS

    OpenAIRE

    Pinheiro, Beth?nia Camargo; Pinheiro, Tiago Novaes; Capelozza, Ana L?cia Alvarez; Consolaro, Alberto

    2008-01-01

    The purpose of this study was to evaluate morphological characteristics of teeth with hypercementosis that are relevant to endodontic practice. Twenty-eight extracted teeth with hypercementosis had their root apexes analyzed by scanning electron microscopy (SEM). The teeth were divided according to tooth groups and type of hypercementosis. The following aspects were examined under SEM: the contour and regularity of the root surface; presence of resorption; presence and number of apical forami...

  10. bioequivalence study on two 10% enrofloxacin oral formulations

    African Journals Online (AJOL)

    AONDOVER

    African grey parrots following single and multiple doses. J. Vet. Pharmacol. Therapeut., 14: 359-. 366. HARITOVA, A., DJENEVA, H.,. LASHEV, L., SOTIROVA, P.,. GYUROV,. B. and. STEFANOVA, M. (2004):. Pharmacokinetics and PK/PD modeling of enrofloxacin in. Meleagris Gallopavo and Gallus. Domesticus. Bulg. J. Vet.

  11. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Science.gov (United States)

    2013-08-26

    ... on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug... availability of a revised draft guidance for industry entitled ``Draft Guidance on Risperidone.'' The guidance... drug applications (ANDAs) for risperidone injection. DATES: Although you can comment on any guidance at...

  12. 21 CFR 320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by...

    Science.gov (United States)

    2010-04-01

    ... appropriate. (3) The proposed chemical and statistical analytical methods are adequate. (c)(1) General... and Drug Administration, Center for Drug Evaluation and Research, Office of Clinical Pharmacology, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. (2) General inquiries relating to bioequivalence...

  13. 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...

  14. Bioequivalent UV detectors based on cholesteric liquid crystals: effects of spectral composition and quantitative account for intensity of UV radiation

    Science.gov (United States)

    Lisetski, Longin N.; Panikarskaya, Valentina D.; Kasyan, Natalya A.; Grishchenko, Leonid V.; Terenetskaya, Irina P.

    2005-11-01

    Response of cholesteric sensor materials to biologically active UV radiation has been studied. The sensor mixture comprised a cholesteric liquid crystalline matrix doped with provitamin D, and changes in the maximum selective reflection wavelength λ max caused by the photochemical reaction of provitamin D --> vitamin D transformation were recorded. Using a UV source (DRT-240 lamp) calibrated accounting for the specific irradiation geometry, λ max shifts were obtained as function of UV illuminance dose (in J/cm2). Using a set of optical filters cutting off specified parts of the provitamin D absorption spectrum, effects of the spectral composition of UV radiation upon the response characteristics of sensor were determined. The results obtained support our earlier considerations of the developed sensor material as "bioequivalent".

  15. Pharmacokinetic properties and bioequivalence of two irbesartan/ hydrochlorothiazide fixed-dose combination tablets in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Jian; Wu, Lihua; Hu, Xingjiang; Wu, Guolan; Zheng, Yunliang; Zhou, Huili; Zhai, You; Zhu, Meixiang; ShenTu, Jianzhong

    2015-07-01

    The aim of the present study was to compare the pharmacokinetic profiles between a new generic and a branded reference formulation of irbesartan/ hydrochlorothiazide FDC tablets, and to assess the bioequivalence of the two products in healthy Chinese male volunteers. 24 male healthy volunteers participated in the open-label, single-dose, randomized-sequence, 2-way crossover study. Eligible subjects were randomly assigned (1:1) to receive a single 300/12.5-mg dose of either the test or reference formulation followed by a 1-week washout. Blood samples were obtained before (0 hours) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours after dosing. Plasma concentrations of irbesartan and hydrochlorothiazide were analyzed by two separate validated liquid chromatography/tandem mass spectrometric (LC-MS/MS) methods. For irbesartan, the 90% confidence intervals (CIs) of AUC0-t, AUC0-∞, and Cmax were 103.27-116.71%, 105.01-121.47%, and 84.15-96.88%, respectively. For hydrochlorothiazide, the 90% CIs of AUC0-t, AUC0-∞, and Cmax were 96.11-109.02%, 95.15-107.35%, and 91.66-101.40%, respectively. A total of 3 mild AEs were reported in 3 subjects (12.5%). In this study, a single dose (300/12.5-mg) of the test formulation of irbesartan and hydrochlorothiazide FDC tablet in fasting healthy Chinese male volunteers met WHO's and China's FDA regulatory criteria for assumption of bioequivalence to the reference formulation based on AUC and Cmax. Both formulations were well tolerated.

  16. Computational Study of Electron Delocalization in Hexaarylbenzenes

    Directory of Open Access Journals (Sweden)

    Citlalli Rios

    2014-03-01

    Full Text Available A number of hexaarylbenzene compounds were studied theoretically, in order to compare energy changes as a result of the toroidal delocalization effect that is characteristic of all these species. The energy was studied taking advantage of locally designed isodesmic reactions. Results indicate that the amount of aromaticity manifested by each substituent is a factor that should be considered when assessing the quantity of energy dissipated from each aromatic center. The influence of different substituents on electronic delocalization is also analyzed, as well as the role played by their frontier molecular orbitals.

  17. Generation and study of relativistic electron beam

    International Nuclear Information System (INIS)

    Iyyengar, S.K.; Ron, P.H.; Mittal, K.C.; Goel, A.K.; Ramaswamy, V.; Rohatgi, V.K.

    1977-01-01

    Pulsed Electron Beam (REB) technology has progressed rapidly in recent years because of applications in various fields like radiation sources, high power laser development, plasma heating and fusion research. The REB development programme at the Plasma Physics Section of Bhabha Atomic Research Centre, Bombay, has been described. The design features of the 375 KV, 3500 A, 75 Joule REB generator are discussed. The diagnostic equipment developed for the studies is described. The present experimental studies and some preliminary results on beam characterisation are presented. (author)

  18. Gamma Putty dosimetric studies in electron beam

    Directory of Open Access Journals (Sweden)

    Aime M Gloi

    2016-01-01

    Full Text Available Traditionally, lead has been used for field shaping in megavoltage electron beams in radiation therapy. In this study, we analyze the dosimetric parameters of a nontoxic, high atomic number (Z = 83, bismuth-loaded material called Gamma Putty that is malleable and can be easily molded to any desired shape. First, we placed an ionization chamber at different depths in a solid water phantom under a Gamma Putty shield of thickness (t = 0, 3, 5, 10, 15, 20, and 25 mm, respectively and measured the ionizing radiation on the central axis (CAX for electron beam ranging in energies from 6 to 20 MeV. Next, we investigated the relationship between the relative ionization (RI measured at a fixed depth for several Gamma Putty shield at different cutout diameters ranging from 2 to 5 cm for various beam energies and derived an exponential fitting equation for clinical purposes. The dose profiles along the CAX show that bremsstrahlung dominates for Gamma Putty thickness >15 mm. For high-energy beams (12-20 MeV and all Gamma Putty thicknesses up to 25 mm, RI below 5% could not be achieved due to the strong bremsstrahlung component. However, Gamma Putty is a very suitable material for reducing the transmission factor below 5% and protecting underlying normal tissues for low-energy electron beams (6-9 MeV.

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

    Science.gov (United States)

    Zarifpour, Mona; Andersson, Karl-Erik; Kelkar, Sneha S; Mohs, Aaron; Mendelsohn, Cathy; Schneider, Kerry; Marini, Frank; Christ, George J

    2017-01-01

    Previous work demonstrated restoration of a bioequivalent bladder within 8 weeks of removing the majority of the bladder (subtotal cystectomy or STC) in rats. The goal of the present study was to extend our investigations of bladder repair to the murine model, to harness the power of mouse genetics to delineate the cellular and molecular mechanisms responsible for the observed robust bladder regrowth. Female C57 black mice underwent STC, and at 4, 8, and 12 weeks post-STC, bladder repair and function were assessed via cystometry, ex vivo pharmacologic organ bath studies, and T 2 -weighted magnetic resonance imaging (MRI). Histology was also performed to measure bladder wall thickness. We observed a time-dependent increase in bladder capacity (BC) following STC, such that 8 and 12 weeks post-STC, BC and micturition volumes were indistinguishable from those of age-matched non-STC controls and significantly higher than observed at 4 weeks. MRI studies confirmed that bladder volume was indistinguishable within 3 months (11 weeks) post-STC. Additionally, bladders emptied completely at all time points studied (i.e., no increases in residual volume), consistent with functional bladder repair. At 8 and 12 weeks post-STC, there were no significant differences in bladder wall thickness or in the different components (urothelium, lamina propria, or smooth muscle layers) of the bladder wall compared with age-matched control animals. The maximal contractile response to pharmacological activation and electrical field stimulation increased over time in isolated tissue strips from repaired bladders but remained lower at all time points compared with controls. We have established and validated a murine model for the study of de novo organ repair that will allow for further mechanistic studies of this phenomenon after, for example, genetic manipulation.

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

    Science.gov (United States)

    Dadey, Eric

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

  1. Electron microscopy study of refractory ceramic fibers.

    Science.gov (United States)

    MacKinnon, P A; Lentz, T J; Rice, C H; Lockey, J E; Lemasters, G K; Gartside, P S

    2001-10-01

    In epidemiological studies designed to identify potential health risks of exposures to synthetic vitreous fibers, the characterization of airborne fiber dimensions may be essential for assessing mechanisms of fiber toxicity. Toward this end, air sampling was conducted as part of an industry-wide study of workers potentially exposed to airborne fibrous dusts during the manufacture of refractory ceramic fibers (RCF) and RCF products. Analyses of a subset of samples obtained on the sample filter as well as on the conductive sampling cowl were performed using both scanning electron microscopy (SEM) and transmission electron microscopy (TEM) to characterize dimensions of airborne fibers. Comparison was made of bivariate fiber size distributions (length and diameter) from air samples analyzed by SEM and by TEM techniques. Results of the analyses indicate that RCF size distributions include fibers small enough in diameter (fibers (> 60 microm) may go undetected by TEM, as evidenced by the proportion of fibers in this category for TEM and SEM analyses (1% and 5%, respectively). Limitations of the microscopic techniques and differences in fiber-sizing rules for each method are believed to have contributed to the variation among fiber-sizing results. It was concluded from these data that further attempts to characterize RCF exposure in manufacturing and related operations should include analysis by TEM and SEM, since the smallest diameter fibers are not resolved with SEM and the fibers of longer length are not sized by TEM.

  2. Auger electron spectroscopy studies of boron carbide

    International Nuclear Information System (INIS)

    Madden, H.H.; Nelson, G.C.; Wallace, W.O.

    1986-01-01

    Auger electron spectroscopy has been used to probe the electronic structure of ion bombardment (IB) cleaned surfaces of B 9 C and B 4 C samples. The shapes of the B-KVV and C-KVV Auger lines were found to be relatively insensitive to the bulk stoichiometry of the samples. This indicates that the local chemical environments surrounding B and C atoms, respectively, on the surfaces of the IB cleaned samples do not change appreciably in going from B 9 C to B 4 C. Fracturing the sample in situ is a way of producing a clean representative internal surface to compare with the IB surfaces. Microbeam techniques have been used to study a fracture surface of the B 9 C material with greater spatial resolution than in our studies of IB surfaces. The B 9 C fracture surface was not homogeneous and contained both C-rich and B-rich regions. The C-KVV line for the C-rich regions was graphitic in shape. Much of the C-rich regions was found by IB to be less than 100 nm in thickness. The C-KVV line from the B-rich regions was carbidic and did not differ appreciably in shape from those recorded for the IB cleaned surfaces

  3. Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations.

    Science.gov (United States)

    Sferrazza, Gianluca; Siviero, Paolo D; Nicotera, Giuseppe; Turella, Paola; Serafino, Annalucia; Blandizzi, Corrado; Pierimarchi, Pasquale

    2017-09-01

    Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field. A focus on oral modified release mesalamine formulations will be also provided, with practical examples of the regulatory pathways followed by pharmaceutical companies to determine bioequivalence. Expert commentary: The development of a scientific rationale to demonstrate bioequivalence in this field has been complex and often associated with uncertainties related to scientific and regulatory aspects. Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs.

  4. Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: impact on bioequivalence.

    Science.gov (United States)

    García-Arieta, Alfredo

    2014-12-18

    The aim of the present paper is to illustrate the impact that excipients may have on the bioavailability of drugs and to review existing US-FDA, WHO and EMA regulatory guidelines on this topic. The first examples illustrate that small amounts of sorbitol (7, 50 or 60mg) affect the bioavailability of risperidone, a class I drug, oral solution, in contrast to what is stated in the US-FDA guidance. Another example suggests, in contrast to what is stated in the US-FDA BCS biowaivers guideline, that a small amount of sodium lauryl sulphate (SLS) (3.64mg) affects the bioavailability of risperidone tablets, although the reference product also includes SLS in an amount within the normal range for that type of dosage form. These factors are considered sufficient to ensure that excipients do not affect bioavailability according to the WHO guideline. The alternative criterion, defined in the WHO guideline and used in the FIP BCS biowaivers monographs, that asserts that excipients present in generic products of the ICH countries do not affect bioavailability if used in normal amounts, is shown to be incorrect with an example of alendronate (a class III drug) tablets, where 4mg of SLS increases bioavailability more than 5-fold, although a generic product in the USA contains SLS. Finally, another example illustrates that a 2mg difference in SLS may affect bioavailability of a generic product of a class II drug, even if SLS is contained in the comparator product, and in all cases its amount was within the normal range. Therefore, waivers of in vivo bioequivalence studies (e.g., BCS biowaivers, waivers of certain dosage forms in solution at the time of administration and variations in the excipient composition) should be assessed more cautiously. Copyright © 2014 Elsevier B.V. All rights reserved.

  5. Forward electron study with the HGTD

    CERN Document Server

    Mauritzsson, Nicholai

    2016-01-01

    A study of the forward region of the ATLAS detector, using $Z\\rightarrow ee$, $\\mu=200$ data, was performed with the goal of decreasing the pile-up effect and improving the reconstruction resolution for electrons using a timing detector (HGTD) in front of the end-cap calorimeters under consideration for the ATLAS upgrade at the high luminosity LHC. The report focuses on the $2.5<|\\eta|<3.5$ region with the \\emph{timing} and \\emph{pre-shower} configuration of the HGTD as well as different $p_T$-cuts. Using the HGTD data the resolution was generally improved for all configuration by 12-15\\% except with the \\emph{timing} configuration at $2.5<|\\eta|<3.0$ which remained unchanged within the statistical errors.

  6. Study of electron-positron interactions

    Energy Technology Data Exchange (ETDEWEB)

    Abashian, A.; Gotow, K.; Philonen, L.

    1990-09-15

    For the past seven years, this group has been interested in the study of tests of the Standard Model of Electroweak interactions. The program has centered about the AMY experiment which examines the nature of the final state products in electron-positron collisions in the center of mass energy range near 60 GeV. Results of these measurements have shown a remarkable consistency with the predictions of the minimal model of 3 quark and lepton generations and single charged and neutral intermediate bosons. No new particles or excited states have been observed nor has any evidence for departures in cross sections or angular asymmetries from expectations been observed. These conclusions have been even more firmly established by the higher energy results from the LEP and SLC colliders at center of mass energies of about 90 GeV. Our focus is shifting to the neutrino as a probe to electroweak interactions. The relative merit of attempting to observe neutrinos from point sources versus observing neutrinos generally is not easy to predict. The improved ability to interpret is offset by the probably episodic nature of the emission and irreproducibility of the results. In this phase of development, it is best to be sensitive to both sources of neutrinos. As a second phase of our program at Virginia Tech, we are studying the feasibility of detecting cosmic ray neutrinos in a proposed experiment which we have called NOVA. the results of the test setup will be instrumental in developing an optimum design. A third program we are involved in is the MEGA experiment at Los Alamos, an experiment to place a limit on the rate of muon decay to electron plus photon which is forbidden by the Standard Model.

  7. Study of electron-positron interactions

    International Nuclear Information System (INIS)

    Abashian, A.; Gotow, K.; Philonen, L.

    1990-01-01

    For the past seven years, this group has been interested in the study of tests of the Standard Model of Electroweak interactions. The program has centered about the AMY experiment which examines the nature of the final state products in electron-positron collisions in the center of mass energy range near 60 GeV. Results of these measurements have shown a remarkable consistency with the predictions of the minimal model of 3 quark and lepton generations and single charged and neutral intermediate bosons. No new particles or excited states have been observed nor has any evidence for departures in cross sections or angular asymmetries from expectations been observed. These conclusions have been even more firmly established by the higher energy results from the LEP and SLC colliders at center of mass energies of about 90 GeV. Our focus is shifting to the neutrino as a probe to electroweak interactions. The relative merit of attempting to observe neutrinos from point sources versus observing neutrinos generally is not easy to predict. The improved ability to interpret is offset by the probably episodic nature of the emission and irreproducibility of the results. In this phase of development, it is best to be sensitive to both sources of neutrinos. As a second phase of our program at Virginia Tech, we are studying the feasibility of detecting cosmic ray neutrinos in a proposed experiment which we have called NOVA. the results of the test setup will be instrumental in developing an optimum design. A third program we are involved in is the MEGA experiment at Los Alamos, an experiment to place a limit on the rate of muon decay to electron plus photon which is forbidden by the Standard Model

  8. Dental Wear: A Scanning Electron Microscope Study

    Directory of Open Access Journals (Sweden)

    Luca Levrini

    2014-01-01

    Full Text Available Dental wear can be differentiated into different types on the basis of morphological and etiological factors. The present research was carried out on twelve extracted human teeth with dental wear (three teeth showing each type of wear: erosion, attrition, abrasion, and abfraction studied by scanning electron microscopy (SEM. The study aimed, through analysis of the macro- and micromorphological features of the lesions (considering the enamel, dentin, enamel prisms, dentinal tubules, and pulp, to clarify the different clinical and diagnostic presentations of dental wear and their possible significance. Our results, which confirm current knowledge, provide a complete overview of the distinctive morphology of each lesion type. It is important to identify the type of dental wear lesion in order to recognize the contributing etiological factors and, consequently, identify other more complex, nondental disorders (such as gastroesophageal reflux, eating disorders. It is clear that each type of lesion has a specific morphology and mechanism, and further clinical studies are needed to clarify the etiological processes, particularly those underlying the onset of abfraction.

  9. Development of novel bepotastine salicylate salt bioequivalent to the commercial bepotastine besilate in beagle dogs.

    Science.gov (United States)

    Cho, Kwan Hyung; Choi, Han-Gon

    2013-06-01

    To develop a novel salt form of bepotastine with bioequivalent to the commericial bepostastine besilate, bepostastine salicylate was prepared and its physicochemical properties were investigated. Furthermore, the bepotastine salicylate-loaded tablet was prepared by the wet granulation method, and the dissolution and bioavailability in beagle dogs were evaluated compared to the bepotastine besilate-loaded commercial product. Bepotastine salicylate improved the solubility of bepotastine, and the extent of solubility improvement by salicylate form was similar to that by besilate form. However, this novel salt exhibited negligible hygroscopicity similar to besilate form, and showed slightly higher melting point than besilate form. It was stable in various pH solutions. Furthermore, the bepotastine salicylate-loaded tablet composed of bepotastine salicylate, microcrystalline cellulose, D-mannitol, povidone, sodium starch glycolate and sodium stearyl fumarate at the weight ratio of 9.63/60.97/38/3.6/6/1.8 showed similar dissolution to the bepotastine besilate-loaded commercial product in water, pH 1.2, pH 4.0 and pH 6.8 and was bioequivalent to the commercial product in beagle dogs. Thus, this bepotastine salicylate-loaded tablet would be a promising candidate with bioequivalence to the bepotastine besilate-loaded commercial product.

  10. Studies on electron transfer reactions of Keggin-type mixed ...

    Indian Academy of Sciences (India)

    Home; Journals; Journal of Chemical Sciences; Volume 121; Issue 2. Studies on electron transfer reactions of Keggin-type mixed addenda heteropolytungstovanadophosphates with NADH ... Nicotinamide adenine dinucleotide (NADH); heteropoly-tungstovanadophosphate; outer sphere electron transfer reactions.

  11. Bioequivalence of locally acting lozenges: Evaluation of critical in vivo parameters and first steps towards a bio-predictive in vitro test method.

    Science.gov (United States)

    Tietz, Katharina; Gutknecht, Sina I; Klein, Sandra

    2018-02-01

    Locally-acting lozenges are among the most common types of solid dosage forms applied in the oral cavity. Since no guidance on the in vitro demonstration of local bioequivalence is available, we wanted to develop a new bio-predictive test method for dissolution of lozenges based on a set of physiological parameters relevant to lozenge dissolution in the oral cavity. An in vivo sucking study determining the impact of different lozenge (candy) bases and flavours on sucking times, saliva osmolality and salivary flow rates was performed in 6 volunteers. In vivo sucking times were compared with in vitro dissolution times observed in experiments with official dissolution methods. In vitro dissolution times of all formulations were significantly longer than average in vivo sucking times (20-30 vs. hard palate during sucking. Results obtained in a first set of in vitro experiments came very close to those obtained in vivo. This novel in vitro approach is thus very promising in terms of predicting the bioequivalence of locally-acting lozenges. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Study of electron and neutrino interactions

    International Nuclear Information System (INIS)

    Abashian, A.

    1997-01-01

    This is the final report for the DOE-sponsored experimental particle physics program at Virginia Tech to study the properties of the Standard Model of strong and electroweak interactions. This contract (DE-AS05-80ER10713) covers the period from August 1, 1980 to January 31, 1993. Task B of this contract, headed by Professor Alexander Abashian, is described in this final report. This program has been pursued on many fronts by the researchers-in a search for axions at SLAC, in electron-positron collisions in the AMY experiment at the TRISTAN collider in Japan, in measurements of muon decay properties in the MEGA and RHO experiments at the LAMPF accelerator, in a detailed analysis of scattering effects in the purported observation of a 17 keV neutrino at Oxford, in a search for a disoriented chiral condensate with the MiniMax experiment at Fermilab, and in an R ampersand D program on resistive plate counters that could find use in low-cost high-quality charged particle detection at low rates

  13. A scanning electron microscopic study of hypercementosis

    Directory of Open Access Journals (Sweden)

    Bethânia Camargo Pinheiro

    2008-12-01

    Full Text Available The purpose of this study was to evaluate morphological characteristics of teeth with hypercementosis that are relevant to endodontic practice. Twenty-eight extracted teeth with hypercementosis had their root apexes analyzed by scanning electron microscopy (SEM. The teeth were divided according to tooth groups and type of hypercementosis. The following aspects were examined under SEM: the contour and regularity of the root surface; presence of resorption; presence and number of apical foramina, and the diameter of the main foramen. The progression of club shape hypercementosis was directly associated with the presence of foramina and apical foramen obstruction. Cases of focal hypercementosis presented foramina on the surface, even when sidelong located in the root. Circular cementum hyperplasia form was present in 2 out of 3 residual roots, which was the highest proportion among the tooth types. The detection of a large number of foramina in the apical third of teeth with hypercementosis or even the possible existence of apical foramen obliteration contributes to understand the difficulties faced during endodontic treatment of these cases.

  14. A scanning electron microscopic study of hypercementosis.

    Science.gov (United States)

    Pinheiro, Bethânia Camargo; Pinheiro, Tiago Novaes; Capelozza, Ana Lúcia Alvarez; Consolaro, Alberto

    2008-01-01

    The purpose of this study was to evaluate morphological characteristics of teeth with hypercementosis that are relevant to endodontic practice. Twenty-eight extracted teeth with hypercementosis had their root apexes analyzed by scanning electron microscopy (SEM). The teeth were divided according to tooth groups and type of hypercementosis. The following aspects were examined under SEM: the contour and regularity of the root surface; presence of resorption; presence and number of apical foramina, and the diameter of the main foramen. The progression of club shape hypercementosis was directly associated with the presence of foramina and apical foramen obstruction. Cases of focal hypercementosis presented foramina on the surface, even when sidelong located in the root. Circular cementum hyperplasia form was present in 2 out of 3 residual roots, which was the highest proportion among the tooth types. The detection of a large number of foramina in the apical third of teeth with hypercementosis or even the possible existence of apical foramen obliteration contributes to understand the difficulties faced during endodontic treatment of these cases.

  15. Electron Cloud Parameterization Studies in the LHC

    CERN Document Server

    Dominguez, O; Baglin, V; Bregliozzi, G; Jimenez, J M; Metral, E; Rumolo, G; Schulte, D; Zimmermann, F

    2011-01-01

    During LHC beam commissioning with 150, 75 and 50-ns bunch spacing, important electron-cloud effects, like pressure rise, cryogenic heat load, beam instabilities or emittance growth, were observed. The main strategy to combat the LHC electron cloud, defined about ten years ago, relies on the surface conditioning arising from the chamber-surface bombardment with cloud electrons. In a standard model, the conditioning state of the beam-pipe surface is characterized by three parameters: 1. most importantly, the secondary emission yield δmax; 2. the incident electron energy at which the yield is maximum, ε_max; and 3. the probability of elastic reflection of low-energy primary electrons hitting the chamber wall, R. Since at the LHC no in-situ secondary-yield measurements are available, we compare the relative local pressure-rise measurements taken for different beam configurations against simulations in which surface parameters are scanned. This benchmarking of measurements and simulations is used to infer the s...

  16. Electron impact study of potassium hydroxide

    Science.gov (United States)

    Vuskovic, L.; Trajmar, S.

    1979-01-01

    An attempt is made to measure the sum of the elastic, rotational and vibrational scattering of electrons by KOH at low impact energies (5 to 20 eV) at angles from 10 to 120 deg. Energy loss spectra taken in the 0 to 18 eV range using an electron impact spectrometer are used to identify the species contributing to electric scattering. At temperatures between 300 and 500 C, only inelastic spectral features belonging to water are detected, while at temperatures from 500 to 800 C strong atomic K lines, indicative of molecular dissociation, and H2 energy loss features become prominent. No features attributable to KOH, the KOH dimer, O2 or potassium oxides were observed, due to the effects of the dissociation products, and it is concluded that another technique will have to be developed in order to measure electron scattering by KOH.

  17. Spectroscopic Studies of the Electron Donor-Acceptor Interaction of ...

    African Journals Online (AJOL)

    Purpose: The electron donor-acceptor interaction between drugs which act as electron donors and some electron-deficient compounds (π acceptors) has severally been utilized as an analytical tool for the quantitation and qualitative assessment of such drugs. The objective of this study, therefore, was to develop an assay ...

  18. Electron Tunneling in Lithium Ammonia Solutions Probed by Frequency-Dependent Electron-Spin Relaxation Studies

    Science.gov (United States)

    Maeda, Kiminori; Lodge, Matthew T.J.; Harmer, Jeffrey; Freed, Jack H.; Edwards, Peter P.

    2012-01-01

    Electron transfer or quantum tunneling dynamics for excess or solvated electrons in dilute lithium-ammonia solutions have been studied by pulse electron paramagnetic resonance (EPR) spectroscopy at both X- (9.7 GHz) and W-band (94 GHz) frequencies. The electron spin-lattice (T1) and spin-spin (T2) relaxation data indicate an extremely fast transfer or quantum tunneling rate of the solvated electron in these solutions which serves to modulate the hyperfine (Fermi-contact) interaction with nitrogen nuclei in the solvation shells of ammonia molecules surrounding the localized, solvated electron. The donor and acceptor states of the solvated electron in these solutions are the initial and final electron solvation sites found before, and after, the transfer or tunneling process. To interpret and model our electron spin relaxation data from the two observation EPR frequencies requires a consideration of a multi-exponential correlation function. The electron transfer or tunneling process that we monitor through the correlation time of the nitrogen Fermi-contact interaction has a time scale of (1–10)×10−12 s over a temperature range 230–290K in our most dilute solution of lithium in ammonia. Two types of electron-solvent interaction mechanisms are proposed to account for our experimental findings. The dominant electron spin relaxation mechanism results from an electron tunneling process characterized by a variable donor-acceptor distance or range (consistent with such a rapidly fluctuating liquid structure) in which the solvent shell that ultimately accepts the transferring electron is formed from random, thermal fluctuations of the liquid structure in, and around, a natural hole or Bjerrum-like defect vacancy in the liquid. Following transfer and capture of the tunneling electron, further solvent-cage relaxation with a timescale of ca. 10−13 s results in a minor contribution to the electron spin relaxation times. This investigation illustrates the great potential

  19. Electron tunneling in lithium-ammonia solutions probed by frequency-dependent electron spin relaxation studies.

    Science.gov (United States)

    Maeda, Kiminori; Lodge, Matthew T J; Harmer, Jeffrey; Freed, Jack H; Edwards, Peter P

    2012-06-06

    Electron transfer or quantum tunneling dynamics for excess or solvated electrons in dilute lithium-ammonia solutions have been studied by pulse electron paramagnetic resonance (EPR) spectroscopy at both X- (9.7 GHz) and W-band (94 GHz) frequencies. The electron spin-lattice (T(1)) and spin-spin (T(2)) relaxation data indicate an extremely fast transfer or quantum tunneling rate of the solvated electron in these solutions which serves to modulate the hyperfine (Fermi-contact) interaction with nitrogen nuclei in the solvation shells of ammonia molecules surrounding the localized, solvated electron. The donor and acceptor states of the solvated electron in these solutions are the initial and final electron solvation sites found before, and after, the transfer or tunneling process. To interpret and model our electron spin relaxation data from the two observation EPR frequencies requires a consideration of a multiexponential correlation function. The electron transfer or tunneling process that we monitor through the correlation time of the nitrogen Fermi-contact interaction has a time scale of (1-10) × 10(-12) s over a temperature range 230-290 K in our most dilute solution of lithium in ammonia. Two types of electron-solvent interaction mechanisms are proposed to account for our experimental findings. The dominant electron spin relaxation mechanism results from an electron tunneling process characterized by a variable donor-acceptor distance or range (consistent with such a rapidly fluctuating liquid structure) in which the solvent shell that ultimately accepts the transferring electron is formed from random, thermal fluctuations of the liquid structure in, and around, a natural hole or Bjerrum-like defect vacancy in the liquid. Following transfer and capture of the tunneling electron, further solvent-cage relaxation with a time scale of ∼10(-13) s results in a minor contribution to the electron spin relaxation times. This investigation illustrates the great

  20. Theoretical study of the electron paramagnetic resonance ...

    Indian Academy of Sciences (India)

    Abstract. The electron paramagnetic resonance (EPR) parameters (the g factors, hy- perfine structure constants and the superhyperfine parameters) for the tetragonal Ir2+ centre in NaCl are theoretically investigated from the perturbation formulas of these parameters for a 5d7 ion in tetragonally elongated octahedra.

  1. A Study Looking the Electronic Funds Transfer

    Directory of Open Access Journals (Sweden)

    Codruta POENAR

    2008-01-01

    Full Text Available The aim of this paper is to present the characteristics of the most important electronic funds transfer in the world, both interperson and interbank. We identified the following informations: location, type, owner, operator, number of transactions, transsactions value, clients, financial scheme and the message format.

  2. Theoretical study of the electron paramagnetic resonance ...

    Indian Academy of Sciences (India)

    conveniently investigated by means of electron paramagnetic resonance (EPR). In ... ion Ir2+ can experience the Jahn–Teller effect by means of vibration interaction, ... Similarly, k. (and k ) are the orbital reduction factors arising from the anisotropic interactions of the orbital angular momentum operator. From the cluster ...

  3. Feasability Study of Electronic Load Sensing Concept

    DEFF Research Database (Denmark)

    Hansen, Michael Rygaard; Andersen, Torben O.; Pedersen, Henrik C.

    2006-01-01

    to traditional LS-systems, in terms of better control and system utilization possibilities, combined with the increased acceptance and use of electronic sensors in mobile hydraulic machinery. The current work is to evaluate the suitability of an ELS concepts applied to a Sauer Danfoss Series 45 H-frame open...

  4. Modified Monte Carlo method for study of electron transport in degenerate electron gas in the presence of electron-electron interactions, application to graphene

    Science.gov (United States)

    Borowik, Piotr; Thobel, Jean-Luc; Adamowicz, Leszek

    2017-07-01

    Standard computational methods used to take account of the Pauli Exclusion Principle into Monte Carlo (MC) simulations of electron transport in semiconductors may give unphysical results in low field regime, where obtained electron distribution function takes values exceeding unity. Modified algorithms were already proposed and allow to correctly account for electron scattering on phonons or impurities. Present paper extends this approach and proposes improved simulation scheme allowing including Pauli exclusion principle for electron-electron (e-e) scattering into MC simulations. Simulations with significantly reduced computational cost recreate correct values of the electron distribution function. Proposed algorithm is applied to study transport properties of degenerate electrons in graphene with e-e interactions. This required adapting the treatment of e-e scattering in the case of linear band dispersion relation. Hence, this part of the simulation algorithm is described in details.

  5. Studies in the electronic structure of matter

    Energy Technology Data Exchange (ETDEWEB)

    Swarts, Coenraad Albert [Univ. of Illinois, Urbana-Champaign, IL (United States)

    1979-01-01

    The results of various theories for the angular distribution of electrons photoemitted from the outermost p-shell of rare gas atoms are compared. The theories compared are the local density theories of Slater (Xα)( Kohn and Sham, the pseudopotential method, Hartree-Fock theory as evaluated by Kennedy and Manson, and Amusia's random phase approximation with exchange (RPAE). Extended Huekel theory is applied to GaAs, GaP, and to the nitrogen isoelectronic trap in GaAs and GaP. The computer perfect crystal band structures are found to be in reasonable agreement with those computed with empirical pseudopotentials. Nitrogen impurity levels in GaAs and GaP are calculated using a cluster model. By means of model calculations for an independent electron metal, exact lineshapes are obtained for the photon absorption, emission and photoemission spectra of deep core states.

  6. Theoretical studies of hollow electron temperature profiles

    International Nuclear Information System (INIS)

    Werkoff, F.; Mercier, C.; Cissoko, G.

    1978-06-01

    The basic mechanisms of experimentally obtained hollow profiles of electron temperature have been investigated. These hollow profiles are obviously related to radiative losses at the center of the plasma, losses that are greater than Joule heating. Hollow profiles were numerically and analytically shown to be instable of the MHD point of view, when the heat diffusion coefficient of electrons is too small. Taking Ksub(e) high enough to satisfy the stability criterion, steady states were obtained in agreement with experimental results. The impurities at the center of the plasma were also shown to be far from the coronal equilibrium. Accoding to neo-classical laws, this discrepancy entails the impurity accumulation at the plasma center, in correlation with an adequately hollow Tsub(e) profile. It was also proved that, at least in a certain range of parameters, the initial conditions can be chosen so as to obtain either a steady peaked state or a steady hollow state [fr

  7. Electronic equipment for atomic nucleus structure studying

    International Nuclear Information System (INIS)

    Brudanin, V.B.; Vasilev, D.; Vylov, Ts.; Zhuravlev, N.I.; Salamatin, A.V.; Sidorov, V.T.; Sinaev, A.N.; Churin, I.N.

    1985-01-01

    The CAMAC electronic equipment used in data acquisition systems for spectrometers intended for investigation of the structure of an atomic nucleus is considered. Specific features of electronic units forming a part of spectrometers for determination of neutrino helicity and three-dimensional amplitude-time measurements as well as electrostatic beta-spectrometer are discussed. Parameters of the MAK-1, the MAK-2 and the MAK-3 multichannel amplitude analyzers developed specially for these spectrometers are given. Accumulation of data coming from analog-to-digital converters and output of recorded spectra on the screens of displays is realized without use of the crate dataway that permits to avoid time losses and to place several analyzers in a crate. Observation of spectra is realized simultaneously with their registration

  8. Studies in the electronic structure of matter

    International Nuclear Information System (INIS)

    Swarts, C.A.

    1979-01-01

    The results of various theories for the angular distribution of electrons photoemitted from the outermost p-shell of rare gas atoms are compared. The theories compared are the local density theories of Slater (X/sub α/) and of Hohenberg, Kohn and Sham, the pseudopotential method, Hartree-Fock theory as evaluated by Kennedy and Manson, and Amusia's random phase approximation with exchange (RPAE). Extended Huekel theory is applied to GaAs, GaP, and to the nitrogen isoelectronic trap in GaAs and GaP. The computer perfect crystal band structures are found to be in reasonable agreement with those computed with empirical pseudopotentials. Nitrogen impurity levels in GaAs and GaP are calculated using a cluster model. By means of model calculations for an independent electron metal, exact lineshapes are obtained for the photon absorption, emission and photoemission spectra of deep core states. 97 references

  9. Dinosaur eggshell study using scanning electron microscopy.

    Science.gov (United States)

    Jackson, Frankie D; Schweitzer, Mary H; Schmitt, James G

    2002-01-01

    Visualization and analysis of structural features in fossil dinosaur eggs by scanning electron microscopy augment information from traditional petrographic light microscopy. Comparison of characteristics in fossil and modern eggshells allows inferences to be made regarding dinosaur reproductive biology, physiology, and evolutionary relationships. Assessment of diagenetic alteration of primary eggshell calcite structure that occurs during fossilization provides important information necessary for taxonomic identification and paleoenvironmental interpretations.

  10. NMR study of strongly correlated electron systems

    Science.gov (United States)

    Kitaoka, Y.; Tou, H.; Zheng, G.-q.; Ishida, K.; Asayama, K.; Kobayashi, T. C.; Kohda, A.; Takeshita, N.; Amaya, K.; Onuki, Y.; Geibel, G.; Schank, C.; Steglich, F.

    1995-02-01

    Various types of ground states in strongly correlated electron systems have been systematically investigated by means of NMR/NQR at low temperatures under high magnetic field and pressure. We focus on two well-known heavy-electron families, CeCu 2X 2 (X = Si and Ge) (Ce(122)) and UM 2Al 3 (M = Ni and Pd) (U(123)). The Cu NQR experiments on CeCu 2X 2 under high pressure indicate that the physical property of CeCu 2Ge 2 at high pressure, i.e. above the transition at 7.6 GPa from antiferromagnetic (AF) to superconductivity, are clearly related to tha CeCu 2Si 2 at ambient pressure. In addition to the H-T phase diagram established below 7 T, NMR and specific heat experiments on polycrystal CeCu 2.05Si 2 have revealed the presence of a new phase above 7 T. In a high-quality polycrystal of UPd 2Al 3 with a record high- Tc of 2 K at ambient pressure and the narrowest Al NQR line width, the nuclear-spin lattice relaxation rate, 27(1/ T1) measured in zero field has been found to obey the T3 law down to 0.13 K, giving strong evidence that the energy gap vanishes along lines on the Fermi surface. Thus it seems that all heavy-electron superconductors exhibit lines of zero gap, regardless of their different magnetic properties.

  11. Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Yamaguchi, Toru; Sako, Hanaka; Takishita, Tomoko; Takagi, Kazunori

    2017-03-01

    In Japan, the development of generic oral dry powder inhaler (DPI) drug products for marketing approval has recently increased. The Pharmaceuticals and Medical Devices Agency (PMDA) considers the required data for each drug product in the consultation meeting. However, guidelines for DPI drug products have been published by the US Food and Drug Administration and the European Medicines Agency. Recently, the basic principles of bioequivalence evaluations of generic DPI drug products were published in March 2016 by the Ministry of Health, Labour and Welfare. The document mainly outlines the current understanding regarding the bioequivalence evaluations of generic DPI drug products based on knowledge from PMDA consultation meetings. In this review, we compared the bioequivalence evaluations of DPI drug products among Japan, USA, and the European Union and discuss future development of generic DPI drug products in Japan.

  12. Physical methods for studying minerals and solid materials: X-ray, electron and neutron diffraction; scanning and transmission electron microscopy; X-ray, electron and ion spectrometry

    International Nuclear Information System (INIS)

    Eberhart, J.-P.

    1976-01-01

    The following topics are discussed: theoretical aspects of radiation-matter interactions; production and measurement of radiations (X rays, electrons, neutrons); applications of radiation interactions to the study of crystalline materials. The following techniques are presented: X-ray and neutron diffraction, electron microscopy, electron diffraction, X-ray fluorescence analysis, electron probe microanalysis, surface analysis by electron emission spectrometry (ESCA and Auger electrons), scanning electron microscopy, secondary ion emission analysis [fr

  13. Study of electron transmission through thin metallic films by the electron moessbauer spectroscopy

    International Nuclear Information System (INIS)

    Babikova, Yu.F.; Vakar, O.M.; Gruzin, O.M.; Petrikin, Yu.V.

    1983-01-01

    Results of the experimental study of the transmission of conversion electrons through aluminium, iron, tin and gold films are presented. Absorption of resonance electrons of the Moessbauer nuclide 57 Fe, formed during target irradiation with γ-quanta of 57 Co source in chromium matrix has been studied. It is asserted that absorption of conversion electrons in films of different elements is similar; at that, like in the case of β-particles, the law of absorption of resonance electrons, emitted from the flat layer, is exponential For conversion electrons of the Moessbauer nuclide 57 Fe the absorption coefficient is (0.025+-0.002) cm 2 /μg, which in the case of iron absorbing film corresponds to (20.0+-1.0)x10 4 cm -1

  14. QTAIM electron density study of natural chalcones

    Science.gov (United States)

    González Moa, María J.; Mandado, Marcos; Cordeiro, M. Natália D. S.; Mosquera, Ricardo A.

    2007-09-01

    QTAIM atomic and bond properties, ionization potential, and O-H bond dissociation energies calculated at the B3LYP/6-311++G(2d,2p) level indicate the natural chalcones bear a significant radical scavenging activity. However, their ionization potentials indicate they decrease the electron-transfer rate between antioxidant and oxygen that yields the pro-oxidative cations less than other natural antioxidants. Rings A and B display slight and similar positive charges, whereas ring B is involved in exocycle delocalization at a larger extension.

  15. Simulation study of secondary electron images in scanning ion microscopy

    CERN Document Server

    Ohya, K

    2003-01-01

    The target atomic number, Z sub 2 , dependence of secondary electron yield is simulated by applying a Monte Carlo code for 17 species of metals bombarded by Ga ions and electrons in order to study the contrast difference between scanning ion microscopes (SIM) and scanning electron microscopes (SEM). In addition to the remarkable reversal of the Z sub 2 dependence between the Ga ion and electron bombardment, a fine structure, which is correlated to the density of the conduction band electrons in the metal, is calculated for both. The brightness changes of the secondary electron images in SIM and SEM are simulated using Au and Al surfaces adjacent to each other. The results indicate that the image contrast in SIM is much more sensitive to the material species and is clearer than that for SEM. The origin of the difference between SIM and SEM comes from the difference in the lateral distribution of secondary electrons excited within the escape depth.

  16. A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers

    Directory of Open Access Journals (Sweden)

    Suyan Tian

    2016-01-01

    Full Text Available In order to test if two chemically or pharmaceutically equivalent products have the same efficacy and/or toxicity, a bioequivalence (BE study is conducted. The 80%/125% rule is the most commonly used criteria for BE and states that BE cannot be claimed unless the 90% CIs for the ratio of selected pharmacokinetics (PK parameters of the tested to the reference drug are within 0.8 to 1.25. Considering that estimates of these PK parameters are derived from the concentration-versus-time curves, a direct comparison between these curves motivates an alternative and more flexible approach to test BE. Here, we propose to frame the BE test in terms of an equivalence of concentration-versus-time curves which are constructed using local polynomial smoother (LPS. A metric is presented to quantify the distance between the curves and its 90% CIs are calculated via bootstrapping. Then, we applied the proposed procedures to data from an animal study and found that BE between a generic drug and its brand name cannot be concluded, which was consistent with the results by applying the 80%/125% rule. However, the proposed procedure has the advantage of testing only on a single metric, instead of all PK parameters.

  17. Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.

    Science.gov (United States)

    Kortejärvi, H; Shawahna, R; Koski, A; Malkki, J; Ojala, K; Yliperttula, M

    2010-02-01

    Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly dissolving (>85% dissolved in 15 min) to be eligible for a biowaiver. Pharmacokinetic modeling of 32 BCS I drugs was performed to demonstrate that very rapid dissolution is not necessary to guarantee bioequivalence for them. Rapid dissolution and similar dissolution profiles are sufficient criteria for all BCS I drugs. (c) 2009 Wiley-Liss, Inc. and the American Pharmacists Association.

  18. 21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

    Science.gov (United States)

    2010-04-01

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

  19. Bioequivalence of budesonide plus formoterol (BF) Spiromax® and BF Turbohaler® (with and without charcoal block) in healthy volunteers.

    Science.gov (United States)

    Weisfeld, Lori; Shu, Youyi; Shah, Tushar P

    2015-07-01

    Budesonide formoterol (BF) Spiromax® is a breath-actuated dry-powder inhaler designed to deliver similar combinations of budesonide and formoterol as Symbicort® Turbohaler®. We performed two studies to demonstrate pharmacokinetic (PK) equivalence of BF Spiromax with BF Turbohaler. Two single-center, open-label, randomized, 5-period crossover studies were performed. The first study compared BF Spiromax 160/4.5 μg with BF Turbohaler 200/6 μg, while the second study compared BF Spiromax 320/9 μg with BF Turbohaler 400/12 μg. All treatments were administered with and without charcoal. PK parameters were calculated by measuring plasma drug concentrations from blood samples taken pre-dose and up to 24 hours post-dose. In each study, 90 healthy volunteers were randomized. Bioequivalence of BF Spiromax with BF Turbohaler was demonstrated for budesonide and formoterol (AUC0-t and Cmax (90% confidence intervals of the geometric mean between-device ratios for both parameters were within the predefined range of 0.80-1.25 in both studies)). Equivalence was observed without use of charcoal (overall absorption post-inhalation) and with charcoal (pulmonary absorption). There were no major differences between treatments in tmax for either budesonide or formoterol. All study treatments were well tolerated (one treatment-emergent adverse event (TEAE) in the medium-dose study and four TEAEs in the high-dose study). These studies indicate that BF Spiromax (±charcoal block) is bioequivalent to BF Turbohaler with respect to the PK parameters assessed. Single doses of BF Spiromax were well tolerated; the overall safety profile of BF Spiromax and BF Turbohaler was similar.

  20. Development techniques and electron optical studies of high voltage, high current electron guns

    International Nuclear Information System (INIS)

    Rangarajan, L.M.; Mahadevan, S.; Ramamurthi, S.S.

    1992-01-01

    The progress of the electron gun design, limiting to axially symmetric geometries is discussed here with a view to utilise such guns for electron accelerators. The mechanical design features leading to the physical configuration of the gun with stringent tolerances are outlined. Vacuum processing is done at pressures of 1.3x10 -5 Pa. The gun employs W-filament emitter or a cathode pellet with bombarder service. A water cooled compact faraday cup is used to measure the electron current. Electron gun geometries have been studied using the computer programme. The preveance of the gun is 0.7x10 -7 A/Vsup(1.5) at 80 kV. Developmental techniques of such pulsed electron guns are described. (author). 7 refs., 5 figs

  1. Studies on electron transfer reactions of Keggin-type mixed ...

    Indian Academy of Sciences (India)

    Administrator

    (PV2) in aqueous phosphate buffer of pH 6 at ambient temperature. Electrochemical and optical studies show that the stoichiometry of the reaction is 1: 2 (NADH : HPA). EPR and optical studies show that HPA act as one electron acceptor and the products of electron transfer reactions are one elec- tron reduced heteropoly ...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-12-18

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

  3. Studies in the electronic structure of matter

    International Nuclear Information System (INIS)

    Swarts, C.A.

    1979-01-01

    Chapter I: Here the results of various theories for the angular distribution of electrons photoemitted from the outermost p-shell of rare gas atoms are compared. The theories compared are (I) the local density theories of Slater (X/sub α/) and of Hohenberg, Kohn and Sham, (II) the pseudopotential method, (III) Hartree-Fock theory as evaluated by Kennedy and Manson, and (IV) Amusia's Random Phase Approximation with Exchange (RPAE). It is shown that the local density theories, although simple, generally fail to produce reliable cross section; the more complicated Hartree-Fock method is no more reliable; the a priori RPAE method is most reliable, but tedious; and the phenomenological pseudopotential method offers a good combination of reliability and simplicity. The muffin-tin approximation, widely used in molecular and condensed matter physics, is examined and found to be adequate. Chapter II: Extended Hueckel theory is applied to GaAs, GaP and to the nitrogen isoelectronic trap in GaAs and GaP. The computed perfect crystal band structures are found to be in reasonable agreement with those computed with empirical pseudopotentials. Nitrogen impurity levels in GaAs and GaP are calculated using a cluster model. Chapter III: By means of model calculations for an independent electron metal, we obtain exact lineshapes for the photon absorption, emission and photoemission spectra of deep core states. We find in each case an X-ray edge anomaly as pedicted by Nozieres and De Dominicis. Sumrules are used as a general check on the calculations and to explain the deviations of the exact theory from the exciton theory away from threshold

  4. 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

  5. Electronic Library of Embrapa Cerrados: user study

    Directory of Open Access Journals (Sweden)

    Maria Elisabeth Salviati

    2015-09-01

    Full Text Available Introduction: This paper presents the results of research conducted with Electronic Library users – website, created in 2004 by Embrapa Cerrados, that organizes, stores, and provides full text of the technical scientific production published by the Institution. Objective: To explore the user profile and to make an accurate assessment of the website. Methodology: Data collection of demographic aspects; habits; and search features: navigation, loading time of pages, help, layout and terminology by an online survey. Analysis by SPSS software - Statistical Package for the Social Sciences. Results: The main users are students and agronomists, young people up to 30 years old, coming from the Federal District, belonging to universities and high schools wishing to update knowledge. After, appear the users of public agencies; private companies; Embrapa; agribusiness; federal government; schools; associations and non-governmental organizations; rural extension; cooperatives and syndicates. These users have no difficulties to use the service. Conclusions: The service works well, but some suggestions are useful to improve it. In addition, little demand coming from farms, ranches, rural extension services, cooperatives and syndicates indicates the need to design new products and services oriented to such public.

  6. Scanning electron microscopic studies on bone tumors

    International Nuclear Information System (INIS)

    Itoh, Motoya

    1978-01-01

    Surface morphological observations of benign and malinant bone tumors were made by the use of scanning electron microscopy. Tumor materials were obtained directly from patients of osteogenic sarcomas, chondrosarcomas, enchondromas, giant cell tumors and Paget's sarcoma. To compare with these human tumors, the following experimental materials were also observed: P 32 -induced rat osteogenic sarcomas with their pulmonary metastatic lesions, Sr 89 -induced transplantable mouse osteogenic sarcomas and osteoid tissues arising after artificial fractures in mice. One of the most outstanding findings was a lot of granular substances seen on cell surfaces and their intercellular spaces in osteoid or chondroid forming tissues. These substances were considered to do some parts in collaborating extracellular matrix formation. Protrusions on cell surface, such as mucrovilli were more or less fashioned by these granular substances. Additional experiments revealed these substances to be soluble in sodium cloride solution. Benign osteoid forming cells, such as osteoblasts and osteoblastic osteosarcoma cells had granular substances on their surfaces and their intercellular spaces. On the other hand, undifferentiated transplantable osteosarcoma which formed on osteoid or chondroid matrix had none of these granular substances. Consequently, the difference of surface morphology between osteosarcoma cells and osteoblasts was yet to be especially concluded. (author)

  7. Theoretical study of lithium clusters by electronic stress tensor

    International Nuclear Information System (INIS)

    Ichikawa, Kazuhide; Nozaki, Hiroo; Komazawa, Naoya; Tachibana, Akitomo

    2012-01-01

    We study the electronic structure of small lithium clusters Li n (n = 2 ∼ 8) using the electronic stress tensor. We find that the three eigenvalues of the electronic stress tensor of the Li clusters are negative and degenerate, just like the stress tensor of liquid. This leads us to propose that we may characterize a metallic bond in terms of the electronic stress tensor. Our proposal is that in addition to the negativity of the three eigenvalues of the electronic stress tensor, their degeneracy characterizes some aspects of the metallic nature of chemical bonding. To quantify the degree of degeneracy, we use the differential eigenvalues of the electronic stress tensor. By comparing the Li clusters and hydrocarbon molecules, we show that the sign of the largest eigenvalue and the differential eigenvalues could be useful indices to evaluate the metallicity or covalency of a chemical bond.

  8. Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

    Science.gov (United States)

    Bate, Roger; Mathur, Aparna; Lever, Harry M; Thakur, Dinesh; Graedon, Joe; Cooperman, Tod; Mason, Preston; Fox, Erin R

    2016-03-01

    The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Contribution to the study of electron paramagnetic resonance and relaxation

    International Nuclear Information System (INIS)

    Theobald, Jean-Gerard

    1962-01-01

    This research thesis reports an experimental work which comprises the development of a very practical and very sensitive electron paramagnetic resonance spectrometer, and the use of this equipment for the study of irradiated substances and carbons. By studying electronic resonance signals by fast modulation of the magnetic field, the author studied phenomena of quick passage in electronic resonance, and showed that the study of these phenomena requires observation systems with a particularly large bandwidth. He reports the measurement of the line width of packs of spins of inhomogeneous lines by two different methods [fr

  10. An empirical study of accessibility and use of electronic information ...

    African Journals Online (AJOL)

    The study therefore recommended provision of access to licensed EIS, fast Internet connectionand pro-activeness of media librarians in creating awareness to available EIS. Keywords: Accessibility; Electronic Information Sources; Journalists; Print Media; Broadcast Media; Electronic Resources Utilization; Nigeria ...

  11. Ultrafast electron diffraction studies of optically excited thin bismuth films

    International Nuclear Information System (INIS)

    Rajkovic, Ivan

    2008-01-01

    This thesis contains work on the design and the realization of an experimental setup capable of providing sub-picosecond electron pulses for ultrafast electron diffraction experiments, and performing the study of ultrafast dynamics in bismuth after optical excitation using this setup. (orig.)

  12. An Empirical Study of Logistics Organization, Electronic Linkage, and Performance

    Science.gov (United States)

    1993-01-01

    Anvari, M., "Electronic Data Interchange and Inventories," International Journal of Production Economics , 26, 1-3 (1992), 135-143. Baker, R. H., EDI: What...Electronic Data Interchange -- A Study of Norwegian Freight Forwarders Using EDI," International Journal of Production Economics , 24 (1991), 91-101. Henry, G

  13. Empirical pseudo-potential studies on electronic structure of ...

    Indian Academy of Sciences (India)

    Home; Journals; Bulletin of Materials Science; Volume 31; Issue 3. Empirical pseudo-potential studies on electronic structure of semiconducting quantum dots. Anjali Kshirsagar Neelesh ... Theoretical investigations of electronic structure of quantum dots is of current interest in nanophase materials. Empirical theories such ...

  14. A comparative study between all-electron scalar relativistic ...

    Indian Academy of Sciences (India)

    Abstract. A comparative study between all-electron relativistic (AER) calculation and all-electron (AE) cal- culation on the H2 molecule adsorption onto small gold clusters has been performed. Compared with the corres- ponding AunH2 cluster obtained by AE method, the AunH2 cluster obtained by AER method has much ...

  15. Comparative study of the electronic structure of natural and synthetic ...

    Indian Academy of Sciences (India)

    Comparative study of the electronic structure of natural and synthetic rubies using XAFS and EDAX analyses ... Electronics and Engineering Research Institute, Pilani 333 031, India; Dipartimento di Fisica, Universita di Roma, “La Sapienza”, 00185 P,le A.Moro, Roma, Italy; Gem Testing Laboratory, Jaipur 302 003, India ...

  16. Ultrafast electron diffraction studies of optically excited thin bismuth films

    Energy Technology Data Exchange (ETDEWEB)

    Rajkovic, Ivan

    2008-10-21

    This thesis contains work on the design and the realization of an experimental setup capable of providing sub-picosecond electron pulses for ultrafast electron diffraction experiments, and performing the study of ultrafast dynamics in bismuth after optical excitation using this setup. (orig.)

  17. Uses of pulsed electron beam to solid-states studies

    International Nuclear Information System (INIS)

    Itoh, Noriaki; Nakayama, Takeyoshi; Tanimura, Katsumi; Chong, Taisu; Saidoh, Masahiro

    1982-01-01

    A survey is given on the use of the pulsed electron beams to studies of solid states. Even though main emphasis is placed on the studies carried out at the Faculty of Engineering, Nagoya University, using the Pulsed Electron Facilities installed in 1970, the works carried out at other institutes are also included. Only the studies of crystalline solids with simple structures, such as alkali halides and aromatic hydrocarbons are covered. In the first place several instrumentations which have extended utilities of pulsed-electron beams are presented. Then we discuss the studies of the dynamic of excitons, emphasizing the advantages and disadvantages of the usage of the electron pulses. Then usages of the pulsed-electron beam for the studies of the excited states of the quasi-stable defects are described. Application of the electron pulse for studies of the excitation spectroscopy of the photochemistry is described. The dynamic studies of defects introduced by electron-pulse bombardment is discussed finally. A summary is given, which includes also the possible future experiments. (author)

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

    Science.gov (United States)

    Itil, T M; Itil, K Z

    1986-09-01

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

  19. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers.

    Science.gov (United States)

    Parrillo-Campiglia, Susana; Ercoli, Mónica Cedres; Umpierrez, Ofelia; Rodríguez, Patricia; Márquez, Sara; Guarneri, Carolina; Estevez-Parrillo, Francisco T; Laurenz, Marilena; Estevez-Carrizo, Francisco E

    2009-10-01

    Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing. The aim of this study was to assess the bioequivalence of a new generic film-coated test tablet formulation versus a film-coated reference tablet formulation of imatinib 400 mg. The local manufacturer seeks to validate the in vitro performance of this new formulation with a bioequivalence study. A randomized, open-label, single-dose, fasting, 2-period, 2-sequence crossover design with a 2-week washout period was used in this study. The study population consisted of healthy male South American (Uruguayan) volunteers, who were assigned in a 1:1 ratio to a randomized sequence (test-reference or reference-test). In each period, the test or reference formulation was administered after an overnight fast. During the 72-hour follow-up period, participants were monitored for vital signs and symptoms. Blood samples were collected at 15 time points, including baseline, until 72 hours. Physical examination and laboratory tests (blood, urine) were repeated 1 week after study completion. A noncompartmental model was used to determine the pharmacokinetic parameters of imatinib. The 90% CIs of the test/reference ratios for AUC(0-infinity) and C(max) were determined; the test and reference formulations were considered bioequivalent if the 90% CIs were between 0.80 and 1.25. Adverse events were assessed by a nurse who administered a questionnaire while the healthy volunteers were admitted in the unit. The bioequivalence study was conducted in 30 Uruguayan male volunteers. Demographic characteristics (mean [SD]) included age, 27.8 (6.5) years; weight, 71.2 (9.8) kg; height, 1.71 (0.09) m; and body

  20. Fast electron studies in the ZT-40M edge plasma

    International Nuclear Information System (INIS)

    Ingraham, J.C.; Ellis, R.F.; Downing, J.N.; Miller, G.; Munson, C.P.; Pickrell, M.M.; Schoenberg, K.F.; Weber, P.G.; Wurden, G.A.

    1990-01-01

    Measurements of the edge plasma on the ZT-40M Reversed Field Pinch (RFP) show the presence of a dilute (1 to 10 per cent of the edge density), fast (T H ≅ (2 - 3)T ε0 ) electron tail with a nearly unidirectional flow along B in a toroidal sense that is against the external applied electric field force. These studies have been extended over a wide range of operating conditions including high density and krypton-injected radiation-dominated (P RAD ≅ 0.9 P IN ) discharges. In all cases the current density of the fast electrons is sufficient to account for the current density required to maintain the RFP. For low current 60 kA discharges this result has been confirmed in to a depth 20 mm inside of the reversal surface suggesting that the source of the fast electrons is the core of the discharge. The fast electrons also carry a large power flux parallel to B (several hundreds of MW/m 2 , typically), and radial transport measurements of the fast electrons in the shadow of a movable limiter for 120 kA standard discharges indicate that the fast electrons are the primary electron energy loss channel. The fast electrons are a significant energy loss channel for a broad range of other cases as well. The collisionality of the fast electrons varies widely over the range of cases studied and it is noted that a small backflowing component of fast electrons increases in relative size as the collisionality increases. An estimate of the magnetic field stochastic diffusivity at the edge is made from the fast electron limiter shadow measurements and shows that the stochasticity of the magnetic field is low at the edge relative to the core, in agreement with magnetic fluctuation diffusivity measurements and MHD simulations. 35 refs., 10 figs

  1. Studies of space charge effects on operating electron beam ion trap at low electron beam energy

    Energy Technology Data Exchange (ETDEWEB)

    Jin, Xuelong; Fei, Zejie; Xiao, Jun; Lu, Di; Hutton, Roger [The Key Lab of Applied Ion Beam Physics, Ministry of Education (China); Shanghai EBIT Laboratory, Modern Physics Institute, Fudan University, Shanghai (China); Zou, Yaming, E-mail: zouym@fudan.edu.cn [The Key Lab of Applied Ion Beam Physics, Ministry of Education (China); Shanghai EBIT Laboratory, Modern Physics Institute, Fudan University, Shanghai (China)

    2013-08-21

    An electron beam ion trap (EBIT) is a powerful machine for disentangling studies of atomic processes in plasmas. To assist studies on edge plasma spectroscopic diagnostics, a very low energy EBIT, SH-PermEBIT, has been set up at the Shanghai EBIT lab. Large amounts of simulation works were done to study the factors which hinder the EBIT from operation at very low electron beam energies. Under the guide line of the simulation results, we finally managed to successfully reach 60 eV for the lower end of the electron beam energy with a beam transmission above 57%. In this presentation, simulation studies of the space charge effect, which is one of the most important causes of beam loss, was made based on Tricomp (Field precision)

  2. Levothyroxine soft capsules demonstrate bioequivalent pharmacokinetic exposure with the European reference tablets in healthy volunteers under fasting conditions.

    Science.gov (United States)

    Al-Numani, Dina; Scarsi, Claudia; Ducharme, Murray P

    2016-02-01

    To assess the bioequivalence (BE) potential under fasting conditions between levothyroxine soft capsules and the European reference tablet formulation. Two studies were conducted to assess the BE potential as per European regulations. Study 1 was a two-way crossover BE study comparing a high strength of levothyroxine soft capsules versus levothyroxine tablets (200 μg), while study 2 was a three-way crossover dosage form proportionality study between low, medium, and high strengths of soft capsules. 70 healthy adult subjects participated in the two studies. Each treatment consisted of a 600-μg dose of levothyroxine sodium, administered under fasting conditions. Blood samples were collected for levothyroxine (T4) assay prior to dosing and up to 72 hours post dose. A washout of 35 days separated treatments in each study. Pharmacokinetics was assessed using noncompartmental methods. A total of 61 subjects completed the studies. Baseline-adjusted total T4 ratios (test/reference) and 90% confidence intervals (CIs) between soft capsules and tablets were within 80.00 - 125.00%. Comparison of the three strengths of soft capsules indicated pharmacokinetic equivalence between them (ratios and 90% CIs were contained within 80.00 - 125.00%). Overall, levothyroxine sodium was well tolerated with all products when given as single oral doses of 600 μg, except for 1 serious adverse event of secondary bacteremia reported in study 2, deemed not to be related to treatment. Levothyroxine soft capsules meet BE criteria in terms of systemic exposure when compared to a European reference tablet under fasting conditions in healthy volunteers.

  3. Experimental study of fast electron propagation in compressed matter

    Science.gov (United States)

    Vauzour, B.; Santos, J. J.; Batani, D.; Baton, S. D.; Koenig, M.; Nicolaï, Ph.; Perez, F.; Beg, F. N.; Benedetti, C.; Benocci, R.; Brambrink, E.; Chawla, S.; Coury, M.; Dorchies, F.; Fourment, C.; Galimberti, M.; Gizzi, L. A.; Heathcote, R.; Higginson, D. P.; Honrubia, J. J.; Hulin, S.; Jafer, R.; Jarrot, L. C.; Labate, L.; Lancaster, K.; Köster, P.; MacKinnon, A. J.; McKenna, P.; McPhee, A. G.; Nazarov, W.; Pasley, J.; Ramis, R.; Rhee, Y.; Regan, C.; Ribeyre, X.; Richetta, M.; Serres, F.; Schlenvoigt, H.-P.; Schurtz, G.; Sgattoni, A.; Spindloe, C.; Vaisseau, X.; Volpe, L.; Yahia, V.

    2011-10-01

    We report on experimental results of the fast electron transport in compressed plasmas, created by laser-induced shock propagation in both cylindrical and planar geometry. Two experiments were carried out. The first one was based on the compression of a polyimide cylinder filled with foams of three different initial densities ( ρ0). X-ray and proton radiographies of the target during the compression coupled with hydrodynamic simulations show that the obtained core densities and temperatures range from 2 to 11 g/cm 3 and from 30 to 120 eV, respectively. By studying the K-shell fluorescence from dopant atoms inside the target and from tracer layers situated at both front and rear side of the target it has been possible to investigate the fast electron propagation. The results show that Cu Kα yield emitted by the target rear side foil decreases with increasing compression, independently of ρ0. An electron collimation can also be observed for certain experimental conditions where a convergent resistivity gradient interacts with the fast electron beam. The second experiment was performed in a planar geometry with a compressing shock counter-propagative to the fast electron beam. In this case the areal density ρz seen by the electrons is constant during the compression in such a way that changes in the fast electron range should be ascribed to collective mechanisms. The study of the Kα fluorescence, from buried fluorescent layers of different atomic numbers, shows that the electrons with energy HiPER project.

  4. Some recent studies of electron swarms in gases

    International Nuclear Information System (INIS)

    Tagashira, H.

    1992-01-01

    Some recent studies of electron swarms in gases under the action of an electric field are introduced. The studies include a new type of continuity equation for electrons having a form in which the partial derivative of the electron density with respect to position and to time are interchanged, a method to deduce the time-of-flight and arrival-time-spectrum swarm parameters based on a Fourier-transformed Boltzmann equation, an examination of the correspondence between experimental and theoretical electron drift velocities, and an automatic technique to deduce the electron-gas molecule collision cross section from electron drift velocity data. A method for the deduction of electron collision cross sections with gas molecules having vibrational excitation cross sections greater than the elastic momentum transfer cross section by using a gas mixture technique, an integral type of method for solution of the Boltzmann equation with salient numerical stability, a quantitative analysis of the effect of Penning ionisation, and the behaviour of electron swarms under radio frequency electric fields, are also briefly discussed. 28 refs., 3 figs

  5. Ultrafast studies of electron dynamics at metal-dielectric interfaces

    Energy Technology Data Exchange (ETDEWEB)

    Ge, Nien-Hui [Univ. of California, Berkeley, CA (United States)

    1998-10-01

    Femtosecond time- and angle-resolved two-photon photoemission spectroscopy has been used to study fundamental aspects of excited electron dynamics at metal-dielectric interfaces, including layer-by-layer evolution of electronic structure and two-dimensional electron localization. On bare Ag(111), the lifetimes of image states are dominated by their position with respect to the projected bulk band structure. The n = 2 state has a shorter lifetime than the n = 1 state due to degeneracy with the bulk conduction band. As the parallel momentum of the n = 1 image electron increases, the lifetime decreases. With decreasing temperatures, the n = 1 image electrons, with zero or nonzero parallel momentum, all become longer lived. Adsorption of one to three layers of n-heptane results in an approximately exponential increase in lifetime as a function of layer thickness. This results from the formation of a tunneling barrier through which the interfacial electrons must decay, consistent with the repulsive bulk electron affinity of n-alkanes. The lifetimes of the higher quantum states indicate that the presence of the monolayer significantly reduces coupling of the image states to the bulk band structure. These results are compared with predictions of a dielectric continuum model. The study of electron lateral motion shows that optical excitation creates interfacial electrons in quasifree states for motion parallel to the n-heptane/Ag(111) interface. These initially delocalized electrons decay into a localized state within a few hundred femtoseconds. The localized electrons then decay back to the metal by tunneling through the adlayer potential barrier. The localization time depends strongly on the electron's initial parallel momentum and exhibits a non-Arrhenius temperature dependence. The experimental findings are consistent with a 2-D self-trapping process in which electrons become localized by interacting with the topmost plane of the alkane layer. The energy

  6. Electronic Freight Management Case Studies : a Summary of Results

    Science.gov (United States)

    2012-04-01

    The Electronic Freight Management (EFM) initiative is a USDOT-sponsored project that applies Web technologies that improve data and message transmissions between supply chain partners. The EFM implementation case studies contained in this document ex...

  7. Electron-ion recombination study in argon at atmospheric pressure

    International Nuclear Information System (INIS)

    Kafrouni, Hanna.

    1979-01-01

    This study deals with a wall-stabilized arc burning in argon at atmospheric pressure. A transient mode is obtained using a fast thyristor connected to the electrodes, which short-circuits the discharge. By means of two wavelengths laser interferometry and spectroscopy measurements we have determined the temporal changes of the electron density, ground state atom density and excited atom density. We have shown that, when the electric field is suppressed, the electron temperature rapidly decreases to the gas temperature before changing electron and atom densities. This phenomenon is applied to determine the gas temperature and to evaluate the role played by ionization in electron density balance. The coefficients of ambipolar diffusion, ionization and recombination and an apparent recombination coefficient are determined versus electron temperature and compared with theoretical values [fr

  8. Study of the electrons elastic scattering by atoms through pseudopotentials

    International Nuclear Information System (INIS)

    Bettega, M.H.F.

    1990-01-01

    Pseudopotentials allow an extraordinary simplification in the calculation of the electronic structure of atoms, molecules and crystals. Though they have been used extensively for electronic structure calculations, little is known of their applicability to scattering. A study of the pseudopotentials of Bachelet, Hamann and Schuter in the electron scattering by atoms was made, calculating phase-shifts and cross sections for angular momenta 1=0,1 and 2 and energy up to 5 R y. The results for the pseudopotential were compared all-electron calculations. The agreement is very good in a broad energy band. A simplification of the calculation of scattering by complex molecules where an all-electron calculation is impossible is aimed. (author)

  9. The effect of food on the pharmacokinetic properties and bioequivalence of two formulations of pitavastatin calcium in healthy Chinese male subjects.

    Science.gov (United States)

    Shang, Dewei; Deng, Shuhua; Yao, Zhenhong; Wang, Zhanzhang; Ni, Xiaojia; Zhang, Ming; Hu, Jinqing; Lu, Haoyang; Zhu, Xiuqing; Huang, Wencan; Qiu, Chang; Wen, Yuguan

    2016-01-01

    1. Pitavastatin is an effective treatment for primary hyperlipidemia and mixed dyslipidemia. The aim of the present study was to investigate the effect of food on the pharmacokinetic properties and bioequivalence of the original, branded, formulation of pitavastatin calcium and a new generic formulation in healthy Chinese male subjects under fasting and fed conditions. 2. Under fasting and fed conditions, 90% CIs of the geometric mean of generic/branded AUC0-48 h ratios were 92.2-102.4%, 93.1-104.5%, the ratios of ln(AUC0-∞) were 92.6-103.7%, 93.2-103.5%, and ln(Cmax) ratios were 90.7-110.3%, 84.7-100.8%, respectively. The generic and branded formulations were bioequivalent in terms of rate and extent of absorption under both the conditions. The average values of AUC0-48 h, AUC0-∞ and Cmax decreased noticeably following a high-fat breakfast. Values for AUC0-48 h were 87.69% and 83.7%, values for AUC0-∞ were 87.5% and 84.6%, and values for Cmax were 45.0% and 50.4% in subjects given the generic and branded preparations, respectively. The absorption of pitavastatin calcium tablets was delayed following a high-fat meal, with Tmax increasing by up to 2.43-fold. 3. Both formulations were generally well tolerated, with no serious adverse reactions reported. The newly developed generic formulation may provide a reliable alternative to the branded tablets for patients with primary hyperlipidemia or mixed dyslipidemia.

  10. Biomedical Studies with the Free Electron Laser

    Science.gov (United States)

    1989-05-15

    disorders includ- Procedure for photosensitization nalignant melanoma has remained ing vitiligo and psoriasis , a logical ex- studies. When tumnors...singlet oxygen which causes irreversible oxidation of this a very attractive form of therapy. Treatment para - some essential cellular component...visible light (red of blue-greenl) delivered by laser was used to treat a paitientf with psoriasis . The psuiriatic les~ons responded vigorously to lawe

  11. Fast electron transport study for inertial confinement fusion

    International Nuclear Information System (INIS)

    Touati, Michael

    2015-01-01

    A new hybrid reduced model for relativistic electron beam transport in solids and dense plasmas is presented. It is based on the two first angular moments of the relativistic kinetic equation completed with the Minerbo maximum angular entropy closure. It takes into account collective effects with the self-generated electromagnetic fields as well as collisional effects with the slowing down of the electrons in collisions with plasmons, bound and free electrons and their angular scattering on both ions and electrons. This model allows for fast computations of relativistic electron beam transport while describing the kinetic distribution function evolution. Despite the loss of information concerning the angular distribution of the electron beam, the model reproduces analytical estimates in the academic case of a collimated and monoenergetic electron beam propagating through a warm and dense Hydrogen plasma and hybrid PIC simulation results in a realistic laser-generated electron beam transport in a solid target. The model is applied to the study of the emission of Kα photons in laser-solid experiments and to the generation of shock waves. (author) [fr

  12. Study of relativistic electron beams generated by a foilless diode

    International Nuclear Information System (INIS)

    Jones, M.E.; Thode, L.E.

    1979-01-01

    Preliminary results of a numerical and analytical study of foilless diodes are presented. The work produced an electron emission algorithm for the particle-in-cell simulation code CCUBE. Diode performance was studied as a function of applied magnetic field strength and simple geometry changes. Annular electron beams with an energy of 5 MeV appear obtainable with densities exceeding 10 14 cm -3 . 8 figures

  13. Study by transmission electron microcospy of activated saponite

    OpenAIRE

    Suárez Barrios, M.; Romero, E.; Santiago, C. de; Martín Pozas, J. M.

    1999-01-01

    This work studies the modifications undergone by the Creen Clays Saponite in the Tagus Basin subjected to activation treatments, and stresses the influence of the development of the electronic microscopy technique for studying these materials. Acid treatment with HCI and pillaring treatment with All3 were performed. Characterization of the samples was carried out by DRX, chemical analysis of major elements and Transmission Electronic Microscopy. Add treament causes the delamination and fragme...

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

    DEFF Research Database (Denmark)

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

    2010-01-01

    AIM: The pharmacokinetic profiles of the two commercially available transdermal fentanyl patches Matrifen (100 microg/h) and Durogesic DTrans (100 microg/h), used to manage severe chronic pain, were compared regarding their systemic exposure, rate of absorption, and safety. METHODS: Transdermal...... matrix fentanyl patches [Matrifen or Durogesic DTrans (100 microg/h)] were applied for 72 h to 30 healthy male subjects in a randomized, four-period (two replicated treatment sequences), crossover study; 28 subjects completed the study. The pharmacokinetic parameters of fentanyl were determined for 144 h...... after application using plasma samples. Safety of the patches (adverse events) and performance (adhesion, skin irritation, residual fentanyl content in the patch) were evaluated. RESULTS: The plasma concentration-time curves of Matrifen (Test) and Durogesic DTrans (Reference) were similar. The geometric...

  15. Role of hot electron transport in scintillators: A theoretical study

    Energy Technology Data Exchange (ETDEWEB)

    Huang, Huihui [SZU-NUS Collaborative Innovation Center for Optoelectronic Science and Technology, Key Lab. of Optoelectronic Devices and Systems of Ministry of Education and Guangdong Province, College of Optoelectronic Engineering, Shenzhen Univ. (China); Li, Qi [Physical Sciences Division, IBM TJ Watson Research Center, Yorktown Heights, NY (United States); Department of Computer Science, University of Illinois at Urbana-Champaign, Urbana, IL (United States); Lu, Xinfu; Williams, R.T. [Department of Physics, Wake Forest University, Winston Salem, NC (United States); Qian, Yiyang [College of Engineering and Applied Science, Nanjing University (China); Wu, Yuntao [Scintillation Materials Research Center, University of Tennessee, Knoxville, TN (United States)

    2016-10-15

    Despite recent intensive study on scintillators, several fundamental questions on scintillator properties are still unknown. In this work, we use ab-initio calculations to determine the energy dependent group velocity of the hot electrons from the electronic structures of several typical scintillators. Based on the calculated group velocities and optical phonon frequencies, a Monte-Carlo simulation of hot electron transport in scintillators is carried out to calculate the thermalization time and diffusion range in selected scintillators. Our simulations provide physical insights on a recent trend of improved proportionality and light yield from mixed halide scintillators. (copyright 2016 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim)

  16. Theoretical studies of the electronic structure of small metal clusters

    Science.gov (United States)

    Jordan, K. D.

    1982-01-01

    Theoretical studies of the electronic structure of metal clusters, in particular clusters of Group IIA and IIB atoms were conducted. Early in the project it became clear that electron correlation involving d orbitals plays a more important role in the binding of these clusters than had been previously anticipated. This necessitated that computer codes for calculating two electron integrals and for constructing the resulting CI Hamiltonions be replaced with newer, more efficient procedures. Program modification, interfacing and testing were performed. Results of both plans are reported.

  17. Optical studies of polarized-electron-noble-gas collisions

    International Nuclear Information System (INIS)

    Gay, T.I.; Furst, J.E.; Geesmann, H.; Khakoo, M.A.; Madison, D.H.; Wijayaratna, W.M.K.P.; Bartschat, K.

    1992-01-01

    We have measured the Stoke's parameters of light emitted following impact excitation of He and Xe by transversely-polarized electrons. For He, the 2 3 S-3 3 P, 389 nm transition was studied in an effort to systematically develop a highly accurate optical electron polarimeter. The 6 3 P 2 -6 3 D 3 , 882 nm transition in Xe was used to assess the importance of spin-dependent forces on the continuum electron for this target. We attempted (and failed) to made the first optical observations of Mott scattering. (Author)

  18. Design studies on high current and grid control electron gun

    International Nuclear Information System (INIS)

    Wang Jinnan; Lu Kun; Chi Yunlong; Zhou Zusheng

    2011-01-01

    Electron gun, the source of electrons, is a kind of ultrahigh vacuum device and plays an important role in different kind of accelerators. With the irradiation accelerator demands, describes the design studies on beam optics optimization. The simulation result shows that the beam current is above 5 A with cathode voltage of 80 kV and beam emittance, gun electric field and beam waist radius meet the accelerator needs. The electron gun manufactured and installed in the test stand, the conditioning and test will be done in the near future. (authors)

  19. Electron microscopy methods in studies of cultural heritage sites

    Energy Technology Data Exchange (ETDEWEB)

    Vasiliev, A. L., E-mail: a.vasiliev56@gmail.com; Kovalchuk, M. V.; Yatsishina, E. B. [National Research Centre “Kurchatov Institute” (Russian Federation)

    2016-11-15

    The history of the development and application of scanning electron microscopy (SEM), transmission electron microscopy (TEM), and energy-dispersive X-ray microanalysis (EDXMA) in studies of cultural heritage sites is considered. In fact, investigations based on these methods began when electron microscopes became a commercial product. Currently, these methods, being developed and improved, help solve many historical enigmas. To date, electron microscopy combined with microanalysis makes it possible to investigate any object, from parchment and wooden articles to pigments, tools, and objects of art. Studies by these methods have revealed that some articles were made by ancient masters using ancient “nanotechnologies”; hence, their comprehensive analysis calls for the latest achievements in the corresponding instrumental methods and sample preparation techniques.

  20. Electron microscopy methods in studies of cultural heritage sites

    International Nuclear Information System (INIS)

    Vasiliev, A. L.; Kovalchuk, M. V.; Yatsishina, E. B.

    2016-01-01

    The history of the development and application of scanning electron microscopy (SEM), transmission electron microscopy (TEM), and energy-dispersive X-ray microanalysis (EDXMA) in studies of cultural heritage sites is considered. In fact, investigations based on these methods began when electron microscopes became a commercial product. Currently, these methods, being developed and improved, help solve many historical enigmas. To date, electron microscopy combined with microanalysis makes it possible to investigate any object, from parchment and wooden articles to pigments, tools, and objects of art. Studies by these methods have revealed that some articles were made by ancient masters using ancient “nanotechnologies”; hence, their comprehensive analysis calls for the latest achievements in the corresponding instrumental methods and sample preparation techniques.

  1. Electronic structure of a striped nickelate studied by the exact exchange for correlated electrons (EECE) approach

    KAUST Repository

    Schwingenschlögl, Udo

    2009-12-01

    Motivated by a RIXS study of Wakimoto, et al.(Phys. Rev. Lett., 102 (2009) 157001) we use density functional theory to analyze the magnetic order in the nickelate La5/3Sr1/3NiO4 and the details of its crystal and electronic structure. We compare the generalized gradient approximation to the hybrid functional approach of exact exchange for correlated electrons (EECE). In contrast to the former, the latter reproduces the insulating state of the compound and the midgap states. The EECE approach, in general, appears to be appropriate for describing stripe phases in systems with orbital degrees of freedom. Copyright © EPLA, 2009.

  2. Clinical utility of topiramate extended-release capsules (USL255): Bioequivalence of USL255 sprinkled and intact capsule in healthy adults and an in vitro evaluation of sprinkle delivery via enteral feeding tubes.

    Science.gov (United States)

    Clark, Annie M; Pellock, John M; Holmay, Mary; Anders, Bob; Cloyd, James

    2016-04-01

    The objectives of these two studies were to determine if beads from extended-release topiramate capsules sprinkled onto soft food are bioequivalent to the intact capsule and if beads from the capsule can be passed through enteral gastrostomy (G-) and jejunostomy (J-) feeding tubes. Bioequivalence of 200-mg USL255 (Qudexy XR [topiramate] extended-release capsules) sprinkled onto soft food (applesauce) versus the intact capsule was evaluated in a phase 1, randomized, single-dose, crossover study (N=36). Pharmacokinetic evaluations included area under the curve (AUC), maximum plasma concentration (Cmax), time to Cmax (Tmax), and terminal elimination half-life (t1/2). If 90% confidence intervals (CI) of the ratio of geometric least-squares means were between 0.80 and 1.25, AUC and Cmax were considered bioequivalent. In separate in vitro experiments, 100-mg USL255 beads were passed through feeding tubes using gentle syringe pressure to develop a clog-free bead-delivery method. Multiple tube sizes (14- to 18-French [Fr] tubes), dilutions (5 mg/15 mL-25 mg/15 mL), and diluents (deionized water, apple juice, Ketocal, sparkling water) were tested. Area under the curve and Cmax for USL255 beads sprinkled onto applesauce were bioequivalent to the intact capsule (GLSM [90% CI]: AUC0-t 1.01 [0.97-1.04], AUC0-∞ 1.02 [0.98-1.05]; Cmax 1.09 [1.03-1.14]). Median Tmax was 4h earlier for USL255 sprinkled versus the intact capsule (10 vs 14 h; p=0.0018), and t1/2 was similar (84 vs 82 h, respectively). In 14-Fr G-tubes, USL255 beads diluted in Ketocal minimized bead clogging versus deionized water. Recovery of USL255 beads diluted in deionized water was nearly 100% in 16-Fr G-, 18-Fr G-, and 18-Fr J-tubes. For patients with difficulty swallowing pills, USL255 sprinkled onto applesauce offers a useful once-daily option for taking topiramate. USL255 beads were also successfully delivered in vitro through ≥14-Fr G- or J-tubes, with tube clogging minimized by portioning the dose and

  3. Study of the niobium dehydrogenation process by transmission electron microscopy

    International Nuclear Information System (INIS)

    Bulhoes, I.A.M.; Akune, K.

    1983-01-01

    The evolution of the micro-structure of Nb-H, during the dehydrogenation process through thermal treatment, has been studied by Transmission Electron Microscopy. The results are used in order to interpret the variation of the line resolution of Electron Channeling Pattern (ECP) of Nb-H as a function of isochronous annealing temperature. It is concluded that the improvement of the ECP line resolution is enhanced of β hydrate in Nb. (Author) [pt

  4. Electron paramagnetic resonance study on irradiated green coffee

    International Nuclear Information System (INIS)

    Brasoveanu, Mirela; Nemtanu, Monica R.; Grecu, Maria Nicoleta

    2006-01-01

    Electron paramagnetic resonance (EPR) is a well-known method for its sensitivity and accuracy in irradiated food detection. Our goal is to analyse the irradiated green coffee by EPR. Arabica beans and grounded coffee was electron beam irradiated up to 40 kGy. The EPR spectra and time dependence of signals were studied. Results were analysed with respect to find a possibility to identify irradiated green coffee. (authors)

  5. Experimental study of fast electron propagation in compressed matter

    Energy Technology Data Exchange (ETDEWEB)

    Vauzour, B. [Universite de Bordeaux - CNRS - CEA, Centre Lasers Intenses et Applications (CELIA), Talence (France); Santos, J.J., E-mail: Santos.Joao@celia.u-bordeaux1.fr [Universite de Bordeaux - CNRS - CEA, Centre Lasers Intenses et Applications (CELIA), Talence (France); Batani, D. [Dipartimento di Fisica, Universita di Milano-Bicocca, Milano (Italy); Baton, S.D.; Koenig, M. [Laboratoire pour l' Utilisation des Lasers Intenses, UMR 7605 CNRS-CEA-Ecole Polytechnique-Univ. Paris VI, Palaiseau (France); Nicolai, Ph. [Universite de Bordeaux - CNRS - CEA, Centre Lasers Intenses et Applications (CELIA), Talence (France); Perez, F. [Laboratoire pour l' Utilisation des Lasers Intenses, UMR 7605 CNRS-CEA-Ecole Polytechnique-Univ. Paris VI, Palaiseau (France); Beg, F.N. [University of California, San Diego, La Jolla (United States); Benedetti, C. [Dipartimento di Fisica, Universita di Bologna, Bologna (Italy); Benocci, R. [Dipartimento di Fisica, Universita di Milano-Bicocca, Milano (Italy); Brambrink, E. [Laboratoire pour l' Utilisation des Lasers Intenses, UMR 7605 CNRS-CEA-Ecole Polytechnique-Univ. Paris VI, Palaiseau (France); Chawla, S. [University of California, San Diego, La Jolla (United States); Coury, M. [SUPA, Department of Physics, University of Strathclyde, Glasgow (United Kingdom); Dorchies, F.; Fourment, C. [Universite de Bordeaux - CNRS - CEA, Centre Lasers Intenses et Applications (CELIA), Talence (France); Galimberti, M. [Central Laser Facility, Rutherford Appleton Laboratory, Didcot (United Kingdom); Gizzi, L.A. [Intense Laser Irradiation Laboratory at INO-CNR, Pisa (Italy); Heathcote, R. [Central Laser Facility, Rutherford Appleton Laboratory, Didcot (United Kingdom); Higginson, D.P. [University of California, San Diego, La Jolla (United States); Honrubia, J.J. [ETSI Aeronauticos, Universidad Politecnica de Madrid, Madrid (Spain); and others

    2011-10-11

    We report on experimental results of the fast electron transport in compressed plasmas, created by laser-induced shock propagation in both cylindrical and planar geometry. Two experiments were carried out. The first one was based on the compression of a polyimide cylinder filled with foams of three different initial densities ({rho}{sub 0}). X-ray and proton radiographies of the target during the compression coupled with hydrodynamic simulations show that the obtained core densities and temperatures range from 2 to 11 g/cm{sup 3} and from 30 to 120 eV, respectively. By studying the K-shell fluorescence from dopant atoms inside the target and from tracer layers situated at both front and rear side of the target it has been possible to investigate the fast electron propagation. The results show that Cu K{sub {alpha}} yield emitted by the target rear side foil decreases with increasing compression, independently of {rho}{sub 0}. An electron collimation can also be observed for certain experimental conditions where a convergent resistivity gradient interacts with the fast electron beam. The second experiment was performed in a planar geometry with a compressing shock counter-propagative to the fast electron beam. In this case the areal density {rho}z seen by the electrons is constant during the compression in such a way that changes in the fast electron range should be ascribed to collective mechanisms. The study of the K{sub {alpha}} fluorescence, from buried fluorescent layers of different atomic numbers, shows that the electrons with energy <75keV are more affected by resistive losses in compressed compared to non-compressed targets. These two experiments were part of the Experimental Fusion Validation Program of the HiPER project.

  6. Early studies of placental ultrastructure by electron microscopy

    DEFF Research Database (Denmark)

    Carter, A M; Enders, A C

    2016-01-01

    BACKGROUND: Transmission electron microscopy (TEM) was first applied to study placental ultrastructure in the 1950's. We review those early studies and mention the scientists that employed or encouraged the use of TEM. FINDINGS: Among the pioneers Edward W. Dempsey was a key figure who attracted...... many other scientists to Washington University in St. Louis. Work on human placental ultrastructure was initiated at Cambridge and Kyoto whilst domestic animals were initially studied by Björkman in Stockholm and electron micrographs of bat placenta were published by Wimsatt of Cornell University...

  7. Topics in recent studies with high-voltage electron microscopes.

    Science.gov (United States)

    Mori, Hirotaro

    2011-01-01

    In this article, topics in recent studies with high-voltage electron microscopes (HVEMs) are reviewed. High-voltage electron microscopy possesses a number of advantages that cannot be afforded by conventional electron microscopy, thus providing a unique microscopy technique in both materials science and biological science. One of these advantages is the capability of continuously observing phenomena using a variety of electron microscopy techniques simultaneously with the introduction of the displacement of atoms from lattice points. This has enabled in-depth studies on such fundamental subjects as the crystalline-to-amorphous-to-crystalline transition, the motion properties of point defects and the one-dimensional diffusion of dislocation loops. Electron tomography studies using HVEMs take advantage of the large observable thickness of a specimen. In addition, by combining different advantages, a number of advanced applications in materials science have been carried out, including analyses of the atomic structure of a reduction-induced reconstructed surface and the atomic mechanism behind the self-catalytic vapor-liquid-solid growth of an oxide nanowire. As long as excellent and invaluable studies that cannot be carried out without HVEMs appear in succession, it is necessary to make the utmost efforts to improve these microscopes.

  8. Electron cloud studies for heavy-ion and proton machines

    CERN Document Server

    Petrov, F; Weiland, Th

    2013-01-01

    Electron cloud effects are a known problem in various accelerator facilities around the world. Electron clouds cause instabilities and emittance growth in positron and proton beams as well as in heavy ion beams. Most of the hadron machines experience the build-up of EC due to the multipacting. In LHC and in positron machines production of electrons due to the synchrotron radiation becomes as important as the build-up due to the secondary emission. The main source of seed electrons in heavy ion machines is the residual gas ionization. FAIR facility in Darmstadt will operate with heavy-ion and proton beams. However, the beam parameters are such that the multipacting will start to play a role only for the unconditioned wall with the secondary emission yieldmore than 1.8. In this paperwe study the electron cloud build-up and its effect on the beam stability for FAIR heavy-ion coasting beams. These beams will be used during slow extraction. Electron scattering on the beam ions and its effect on the final neutraliz...

  9. Improving outpatient safety through effective electronic communication: a study protocol.

    Science.gov (United States)

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-09-25

    Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis.

  10. Experimental study of fast electron transport in dense plasmas

    International Nuclear Information System (INIS)

    Vaisseau, Xavier

    2014-01-01

    The framework of this PhD thesis is the inertial confinement fusion for energy production, in the context of the electron fast ignition scheme. The work consists in a characterization of the transport mechanisms of fast electrons, driven by intense laser pulses (10 19 - 10 20 W/cm 2 ) in both cold-solid and warm-dense matter. The first goal was to study the propagation of a fast electron beam, characterized by a current density ≥ 10 11 A/cm 2 , in aluminum targets initially heated close to the Fermi temperature by a counter-propagative planar shock. The planar compression geometry allowed us to discriminate the energy losses due to the resistive mechanisms from collisional ones by comparing solid and compressed targets of the same initial areal densities. We observed for the first time a significant increase of resistive energy losses in heated aluminum samples. The confrontation of the experimental data with the simulations, including a complete characterization of the electron source, of the target compression and of the fast electron transport, allowed us to study the time-evolution of the material resistivity. The estimated resistive electron stopping power in a warm-compressed target is of the same order as the collisional one. We studied the transport of the fast electrons generated in the interaction of a high-contrast laser pulse with a hollow copper cone, buried into a carbon layer, compressed by a counter-propagative planar shock. A X-ray imaging system allowed us to visualize the coupling of the laser pulse with the cone at different moments of the compression. This diagnostic, giving access to the fast electron spatial distribution, showed a fast electron generation in the entire volume of the cone for late times of compression, after shock breakout from the inner cone tip. For earlier times, the interaction at a high-contrast ensured that the source was contained within the cone tip, and the fast electron beam was collimated into the target depth by

  11. Electronic journals and scholarly communication: a citation and reference study

    Directory of Open Access Journals (Sweden)

    Stephen P. Harter

    1996-01-01

    Full Text Available The journal is fundamental to formal scholarly communication. This research reports highlights and preliminary findings from an empirical study of scholarly electronic journals. The purpose of the research is to assess the impact of electronic journals (e-journals on scholarly communication, by measuring the extent to which they are being cited in the literature, both print and electronic. The intent is to provide a snapshot of the impact e-journals were having on scholarly communication at a given point in time, roughly the end of 1995. This study provides one measure of that impact, specifically on the formal, as opposed to informal, communication process. The study also examines the forms in which scholars cite e-journals, the accuracy and completeness of citations to e-journals, and practical difficulties faced by scholars and researchers who wish to retrieve e-journals through the networks.

  12. Progresses in low energy electron microscopy and photoemission electron microscopy studies (LEEM and PEEM)

    International Nuclear Information System (INIS)

    Koshikawa, Takanori; Yasue, Tsuneo; Kobayashi, Keisuke; Kinoshita, Toyohiko; Ono, Kanta

    2008-02-01

    Photon factory workshop on low energy electron microscopy (LEEM) and photoemission electron microscopy (PEEM) studies was held on October 12-13, 2005. The workshop had 18 presentations and 8 contributions to the poster session with 62 attendees. The workshop started with an invitation presentation about nano-imaging and nano-spectroscopy by photoemission electron microscope using synchrotron radiation x-rays. Next two reports were about antiferromagnetic domain structure observations of a NiO(100) surface using a combined method of PEEM and soft x-ray linear dichroism. Recent development of spin SEM (scanning electron microscope) and the observation of magnetic domains of La 1.36 Sr 1.64 Mn 2 O 7 were reported. A new method for observing magnetic domain structures with SEM was developed in which the image is the result of spin polarization of secondary electrons. This method is called spin SEM. A lecture about observation of ultra-high speed phenomena by PEEM and the invitation presentation about spin dynamics in nano-scale magnetic materials attracted much attention. Structural studies of surfaces by LEEM and PEEM were actively discussed. Summaries about the measurements of Au-Si alloy island at atomic steps on Si(111), fabrication of Ga nano-dots in SiO 2 , growth of pentacene films on thin bismuth film and graphite, the surface phase transition on metal surfaces of In/Cu(001) and Sn/Cu(001), and Cu thin film growth on W(110) were also compiled in this report. Many contributions in this report were resulted from the experiments by LEEM and PEEM using SPring-8 synchrotron radiations. (Y.K.)

  13. Studies of runaway electrons via Cherenkov effect in tokamaks

    Science.gov (United States)

    Zebrowski, J.; Jakubowski, L.; Rabinski, M.; Sadowski, M. J.; Jakubowski, M. J.; Kwiatkowski, R.; Malinowski, K.; Mirowski, R.; Mlynar, J.; Ficker, O.; Weinzettl, V.; Causa, F.; COMPASS; FTU Teams

    2018-01-01

    The paper concerns measurements of runaway electrons (REs) which are generated during discharges in tokamaks. The control of REs is an important task in experimental studies within the ITER-physics program. The NCBJ team proposed to study REs by means of Cherenkov-type detectors several years ago. The Cherenkov radiation, induced by REs in appropriate radiators, makes it possible to identify fast electron beams and to determine their spatial- and temporal-characteristics. The results of recent experimental studies of REs, performed in two tokamaks - COMPASS in Prague and FTU in Frascati, are summarized and discussed in this paper. Examples of the electron-induced signals, as recorded at different experimental conditions and scenarios, are presented. Measurements performed with a three-channel Cherenkov-probe in COMPASS showed that the first fast electron peaks can be observed already during the current ramp-up phase. A strong dependence of RE-signals on the radial position of the Cherenkov probe was observed. The most distinct electron peaks were recorded during the plasma disruption. The Cherenkov signals confirmed the appearance of post-disruptive RE beams in circular-plasma discharges with massive Ar–puffing. During experiments at FTU a clear correlation between the Cherenkov detector signals and the rotation of magnetic islands was identified.

  14. Postponed variety creation: case study in consumer electronics retail

    DEFF Research Database (Denmark)

    Appelqvist, Patrik; Gubi, Ebbe

    2004-01-01

    Purpose – Postponement is known as a way to reduce risk and inventories while still providing high product variety and acceptable response times. The paper is a case study that uses simulation for quantifying these benefits for a consumer electronics company. Design/methodology/approach – Improve......Purpose – Postponement is known as a way to reduce risk and inventories while still providing high product variety and acceptable response times. The paper is a case study that uses simulation for quantifying these benefits for a consumer electronics company. Design...

  15. Postponed variety creation: case study in consumer electronics retail

    DEFF Research Database (Denmark)

    Appelqvist, Patrik; Gubi, Ebbe

    2005-01-01

    Purpose – Postponement is known as a way to reduce risk and inventories while still providing high product variety and acceptable response times. The paper is a case study that uses simulation for quantifying these benefits for a consumer electronics company. Design/methodology/approach – Improve......Purpose – Postponement is known as a way to reduce risk and inventories while still providing high product variety and acceptable response times. The paper is a case study that uses simulation for quantifying these benefits for a consumer electronics company. Design...

  16. High-pressure electron-resonance studies of electronic, magnetic, and structural phase transitions. Progress report

    International Nuclear Information System (INIS)

    Pifer, J.H.; Croft, M.C.

    1983-01-01

    Research is described in development of a high-pressure electron-resonance probe capable of operating down to 1.5 0 K temperatures. The apparatus has been used to measure the EPR of a sample of DPPH at room temperature and zero pressure. EPR has been used to measure valence field instabilities in alloy systems. Studies have been done on metal-insulator transitions at high pressure, and are briefly described

  17. Electron holography study on the microstructure of magnetic tunnelling junctions

    International Nuclear Information System (INIS)

    Xu, Q.Y.; Wang, Y.G.; You, B.; Du, J.; Hu, A.; Zhang, Z.

    2004-01-01

    Electron holography was applied to study the microstructure evolution of magnetic tunnelling junctions (MTJs) CoFe/AlO x /Co annealed at different temperatures. A mean inner potential barrier was observed in the as-deposited MTJ sample, while it was changed to a potential well after a 200 deg. C or a 400 deg. C annealing. It is suggested that the oxygen atoms were redistributed during the annealing, which left metallic atoms acting as acceptors to confine the electrons, leading to the decrease of the potential of the AlO x barrier layer. The results suggest that the electron holography may be a useful tool for the study of the microstructure of amorphous materials

  18. Optical studies of pre-breakdown electron avalanches

    International Nuclear Information System (INIS)

    Blevin, H.A.; Fletcher, J.

    1992-01-01

    This paper reviews the work carried out at Flinders University over a number of years in relation to the light output from pre-breakdown Townsend discharges and isolated electron swarms. This 'luminous flux' technique has important advantages over conventional current measurements since regions remote from electrode boundaries can be studied yielding values of electron drift velocity, diffusion coefficients and ionisation/attachment rates from a single experiment. For the first time the internal structure of a single swarm has been studied by observing the light from different excited states. From these results it is clear that, in many cases, the diffusion equation does not give an adequate description of the spatial and temporal development of electron concentration, and higher order transport parameters are required in the analysis of experiments. Thus the behaviour of the C state radiation in nitrogen is not fully understood, yet. For example, available cross sections used in a Monte Carlo simulation yield excitation reaction rates approximately 50% of the observed values. Similarly, whilst secondary electron data in hydrogen are consistent with the suggested theory, in nitrogen the shape of the time resolved ion-produced secondary electron curves cannot be fully explained. 37 refs., 7 fig

  19. Design studies for the next generation electron ion colliders

    Energy Technology Data Exchange (ETDEWEB)

    Sayed, Hisham Kamal [BNL; Bogacz, Slawomir A. [JLAB; Krafft, Geoffrey A. [JLAB

    2014-04-01

    The next generation Electron Ion Collider (EIC) at Thomas Jefferson National Accelerator Facility (JLAB) utilizes a figure-8 shaped ion and electron rings. EIC has the ability to preserve the ion polarization during acceleration, where the electron ring matches in footprint with a figure-8 ion ring. The electron ring is designed to deliver a highly polarized high luminous electron beam at interaction point (IP). The main challenges of the electron ring design are the chromaticity compensation and maintaining high beam polarization of 70% at all energies 3–11 GeV without introducing transverse orbital coupling before the IP. The very demanding detector design limits the minimum distance between the final focus quadrupole and the interaction point to 3.5 m which results in a large β function inside the final focus quadrupoles leading to increased beam chromaticity. In this paper, we present a novel chromaticity compensation scheme that mitigates IP chromaticity by a compact chromaticity compensation section with multipole magnet components. In addition, a set of spin rotators are utilized to manipulate the polarization vector of the electron beam in order to preserve the beam polarization. The spin rotator solenoids introduce undesired coupling between the horizontal and vertical betatron motion of the beam. We introduce a compact and modular orbit decoupling insert that can fit in the limited space of the straight section in the figure-8 ring. We show a numerical study of the figure-8 ring design with the compact straight section, which includes the interaction region, chromaticity compensation section, and the spin rotators, the figure-8 design performance is evaluated with particle tracking.

  20. Dynamic electron arc radiotherapy (DEAR): a feasibility study

    International Nuclear Information System (INIS)

    Rodrigues, Anna; Yin, Fang-Fang; Wu, Qiuwen

    2014-01-01

    Compared to other radiation therapy modalities, clinical electron beam therapy has remained practically unchanged for the past few decades even though electron beams with multiple energies are widely available on most linacs. In this paper, we present the concept of dynamic electron arc radiotherapy (DEAR), a new conformal electron therapy technique with synchronized couch motion. DEAR utilizes combination of gantry rotation, couch motion, and dose rate modulation to achieve desirable dose distributions in patient. The electron applicator is kept to minimize scatter and maintain narrow penumbra. The couch motion is synchronized with the gantry rotation to avoid collision between patient and the electron cone. In this study, we investigate the feasibility of DEAR delivery and demonstrate the potential of DEAR to improve dose distributions on simple cylindrical phantoms. DEAR was delivered on Varian's TrueBeam linac in Research Mode. In conjunction with the recorded trajectory log files, mechanical motion accuracies and dose rate modulation precision were analyzed. Experimental and calculated dose distributions were investigated for different energies (6 and 9 MeV) and cut-out sizes (1×10 cm 2  and 3×10 cm 2  for a 15×15 cm 2  applicator). Our findings show that DEAR delivery is feasible and has the potential to deliver radiation dose with high accuracy (root mean square error, or RMSE of <0.1 MU, <0.1° gantry, and <0.1 cm couch positions) and good dose rate precision (1.6 MU min −1 ). Dose homogeneity within ±2% in large and curved targets can be achieved while maintaining penumbra comparable to a standard electron beam on a flat surface. Further, DEAR does not require fabrication of patient-specific shields. These benefits make DEAR a promising technique for conformal radiotherapy of superficial tumors. (paper)

  1. Study of fast electrons from hard-X radiation

    International Nuclear Information System (INIS)

    Arslanbekov, R.

    1995-01-01

    The goal of this thesis is the study of fast electron dynamics by means of the hard X-ray diagnosis installed in TORE SUPRA and numerical simulations. Fast electrons are generated in the plasma in the presence of the injected lower hybrid (LH) waves. Two aspects are studied in detail: the lower hybrid wave propagation and absorption in a periodically perturbed media and 2-D Fokker-Planck modelling of the fast electron dynamics in the presence of the LH power. Ripple effects on lower hybrid wave propagation and absorption are investigated using the ray tracing technique. A cylindrical equilibrium is first studied and a strong modification of the ray dynamics is predicted. Calculations are carried out in a real toroidal geometry corresponding to TORE SUPRA. It is shown that the lack of toroidal axisymmetry of the magnetic field may result in a modification of the ray evolution even if the global ray evolution is governed by the larger poloidal inhomogeneity. Simulation of LH experiments are performed for TORE SUPRA tokamak which has a large magnetic ripple (7% at the plasma edge). By considering ripple perturbation in LH current drive simulations, a better agreement is found with experimental results, in particular with the hard-X spectra and the current density profiles. In the second part of the thesis, a 2-D modeling of the fast electron dynamics in the velocity phase space is considered, based on the 2-D relativistic electron Fokker-Planck equation. Electron distribution functions obtained are used to calculate non-thermal Bremsstrahlung emission for different TORE SUPRA shots in a wide range of experimental conditions. (J.S.). 168 refs., 93 figs., 1 tab., 3 appendix

  2. Study and realization of an electron linear accelerator. Dynamics of accelerated electrons

    International Nuclear Information System (INIS)

    Bernard, J.

    1966-12-01

    The theoretical characteristics of the electron linear accelerator are: 30 MeV for the energy W S and 250 mA for the peak current I c . The main utilization is the intense production of fast neutrons by the reactions (γ,n) and (γ,f) induced in a target of natural uranium by the accelerated electrons. In the first part of the thesis, relative to the study and the realization of the accelerator, a new equation of dispersion is established analytically when the guide is loaded with round-edged irises. The relation is compared with the equation established by CHU and Hansen, WALKINSHAW, KVASIL in the case of a guide loaded with flat-edged irises. The experimental and theoretical curves of dispersion are compared. The accuracy of every relation of dispersion is estimated. The second part of the thesis is relative to the theoretical study of the electrons dynamics in the guide; it allows the derivation of the parameters of the beam: dispersion of phase, energy, dispersion of energy and the relation W S = f (I c ). The results relative to the first experiments are given and compared with the theoretical expectations. (author) [fr

  3. Experimental study of intensive electron beam scattering in melting channel

    International Nuclear Information System (INIS)

    Balagura, V.S.; Kurilko, V.I.; Safronov, B.G.

    1988-01-01

    Multiple scattering of an intensive electron beam at 28 keV energy passing through a melting channel in iron targets is experimentally studied. The dependence of scattering on the melting current value is established. The material density in the channel on the basis of the binary collision method is evaluated. It is shown that these density values are of three orders less than the estimations made on the basis of the data on energy losses of electrons in the channel. 6 refs.; 4 figs

  4. Surface study of liquid 3He using surface state electrons

    International Nuclear Information System (INIS)

    Shirahama, K.; Ito, S.; Suto, H.; Kono, K.

    1995-01-01

    We have measured the mobility of surface state electrons (SSE) on liquid 3 He, μ 3 , aiming to study the elementary surface excitations of the Fermi liquid. A gradual increase of μ 3 below 300 mK is attributed to the scattering of electrons by ripplons. Ripplons do exist in 3 He down to 100 mK. We observe an abrupt decrease of μ 3 , due to the transition to the Wigner solid (WS). The dependences of the WS conductivity and mobility on temperature and magnetic field differ from the SSE behavior on liquid 4 He

  5. A Comparative Study of Electronic Performance Support Systems

    Science.gov (United States)

    Nguyen, Frank; Klein, James D.; Sullivan, Howard

    2005-01-01

    Electronic performance support systems (EPSS) deliver relevant support information to users while they are performing tasks. The present study examined the effect of different types of EPSS on user performance, attitudes, system use and time on task. Employees at a manufacturing company were asked to complete a procedural software task and…

  6. Bipolar budding in yeasts - an electron microscope study

    NARCIS (Netherlands)

    Kreger-van Rij, N.J.W.; Veenhuis, M.

    1971-01-01

    Bud formation in yeasts with bipolar budding was studied by electron microscopy of thin sections. Budding in yeasts of the species Saccharomycodes ludwigii, Hanseniaspora valbyensis and Wickerhamia fluorescens resulted in concentric rings of scar ridges on the wall of the mother cell. The wall

  7. The structure of spinach Photosystem I studied by electron microscopy

    NARCIS (Netherlands)

    Boekema, Egbert J.; Wynn, R. Max; Malkin, Richard

    1990-01-01

    The structure of three types of Photosystem I (PS I) complex isolated from spinach chloroplasts was studied by electron microscopy and computer image analysis. Molecular projections (top views and side views) of a native PS I complex (PSI-200), an antenna-depleted PS I complex (PSI-100) and the PS I

  8. A microspectroscopic study of the electronic homogeneity of ordered ...

    Indian Academy of Sciences (India)

    Home; Journals; Journal of Chemical Sciences; Volume 118; Issue 1. A microspectroscopic study of the electronic homogeneity of ordered and disordered Sr2FeMoO6. Dinesh Topwal U Manju Sugata Ray S Raj D D Sarma S R Krishnakumar M Bertolo S La Rosa G Cautero. Volume 118 Issue 1 January 2006 pp 87-92 ...

  9. Histological and electron microscopic study of the postulated ...

    African Journals Online (AJOL)

    kemrilib

    CL; Wang H and Heber D. Bioavailability and antioxidant effect of epigallocatechin gallate administered in purified form versus as green tea extract in healthy individuals. Journal of Nutritional. Biochemistry. 2005; 16:610-6. 13. Ahmed A & Hosney S. Light and electron microscopic study of the effect of furosemide on the liver ...

  10. Electronic Structure of Complex Materials: from First-principles study ...

    Indian Academy of Sciences (India)

    Electronic Structure of Complex Materials: from. First-principles study to Materials Modeling. Tanusri Saha-Dasgupta. Dept. of Materials Science & Advanced Materials. Research Unit. S.N. Bose National Centre for Basic Sciences. Salt Lake, Calcutta, INDIA http://www.bose.res.in/∼tanusri/ . – p.1/25 ...

  11. Electron microscopy studies on MoS2 nanocrystals

    DEFF Research Database (Denmark)

    Hansen, Lars Pilsgaard

    Industrial-style MoS2-based hydrotreating catalysts are studied using electron microscopy. The MoS2 nanostructures are imaged with single-atom sensitivity to reveal the catalytically important edge structures. Furthermore, the in-situ formation of MoS2 crystals is imaged for the first time....

  12. [Scanning electron microscope study of chemically disinfected endodontic files].

    Science.gov (United States)

    Navarro, G; Mateos, M; Navarro, J L; Canalda, C

    1991-01-01

    Forty stainless steel endodontic files were observed at scanning electron microscopy after being subjected to ten disinfection cycles of 10 minutes each one, immersed in different chemical disinfectants. Corrosion was not observed on the surface of the files in circumstances that this study was made.

  13. Electron cyclotron resonance breakdown studies in a linear plasma ...

    Indian Academy of Sciences (India)

    Abstract. Electron cyclotron resonance (ECR) plasma breakdown is studied in a small linear cylindrical system with four different gases – hydrogen, helium, argon and nitrogen. Microwave power in the experimental system is delivered by a magnetron at 2.45 ± 0.02. GHz in TE10 mode and launched radially to have ...

  14. Studies on tin oxide films prepared by electron beam evaporation ...

    Indian Academy of Sciences (India)

    Unknown

    Abstract. Transparent conducting tin oxide thin films have been prepared by electron beam evaporation and spray pyrolysis methods. Structural, optical and electrical properties were studied under different pre- paration conditions like substrate temperature, solution flow rate and rate of deposition. Resistivity of un-.

  15. Studies on tin oxide films prepared by electron beam evaporation ...

    Indian Academy of Sciences (India)

    Transparent conducting tin oxide thin films have been prepared by electron beam evaporation and spray pyrolysis methods. Structural, optical and electrical properties were studied under different preparation conditions like substrate temperature, solution flow rate and rate of deposition. Resistivity of undoped evaporated ...

  16. Preliminary Design Study of the Hollow Electron Lens for LHC

    CERN Document Server

    Perini, Diego; CERN. Geneva. ATS Department

    2017-01-01

    A Hollow Electron Lens (HEL) has been proposed in order to improve performance of halo control and collimation in the Large Hadron Collider in view of its High Luminosity upgrade (HL-LHC). The concept is based on a beam of electrons that travels around the protons for a few meters. The electron beam is produced by a cathode and then guided by a strong magnetic field generated by a set of superconducting solenoids. The first step of the design is the definition of the magnetic fields that drive the electron trajectories. The estimation of such trajectories by means of a dedicated MATLAB® tool is presented. The influence of the main geometrical and electrical parameters are analysed and discussed. Then, the main mechanical design choices for the solenoids, cryostats gun and collector are described. The aim of this paper is to provide an overview of the preliminary design of the Electron Lens for LHC. The methods used in this study also serve as examples for future mechanical and integration designs of similar ...

  17. A design study of non-adiabatic electron guns

    International Nuclear Information System (INIS)

    Barroso, J.J.; Stellati, C.

    1994-01-01

    The design of a non-adiabatic gun capable of producing a 10 A, 50 KeV high-quality laminar electron beam is reported. In contrast to the magnetron injection gun with a conical cathode, where the beam is generated initially with a transverse velocity component, in the non-adiabatic gun electrons are extracted in a direction parallel to the axial guide magnetic field. The beam electrons acquire cyclotron motion as result of non-adiabatic processes in a strong non uniform electric field across the modulation anode. Such an extraction method gives rise to favourable features that are explored throughout the work. An extensive numerical simulation study has also been done to minimize velocity and energy spreads. (author). 3 refs, 5 figs, 1 tab

  18. Neo-Institutional Approach to the Study of Electronic Government

    Directory of Open Access Journals (Sweden)

    Yan I. Vaslavskiy

    2016-01-01

    Full Text Available The article is devoted to the neo-institutional approach as a methodological basis in the study of electronic government. In this article substantiates the choice of neo-institutional approach to the study of the processes of implementation of information and communication technologies in the activity of state institutions, analyzes the differences of neoinstitutionalism from traditional institutional approach, considers the features of the different directions of neo-institutionalism, namely sociological, historical and rational choice theory. Attention is paid to the reasons for the renewed interest in political institutions in political science. The article emphasizes the importance of considering the electronic government as an institution, and the conditions for its implementation in the Russian political system as the institutional environment. The authors pay special attention to the variety of sociological neo-institutionalism, used, in addition to political science in sociology of organizations. The article substantiates the value of using sociological institutionalism to explore the electronic government based on a comparative analysis of e-government projects in Russia and abroad and explores its heuristic capabilities. It examines the impact of the system of norms and values of the institutional environment on the processes of formation and development of electronic government in Russia. The research capacity of this theory is due to the fact that it allows us to trace the reasons for copying and replication of inefficient practices and organizational and management schemes, to identify the factors impeding innovation use by the state of electronic interaction technologies. It is emphasized that the use of the theory of institutional isomorphism is useful in the sphere of implementation of electronic technologies, in which a key role play pluralism, horizontal managerial communication, inter-agency coordination.

  19. ANALYTICAL REVIEW OF ELECTRONIC RESOURCES FOR THE STUDY OF LATIN

    Directory of Open Access Journals (Sweden)

    Olena Yu. Balalaieva

    2014-04-01

    Full Text Available The article investigates the current state of development of e-learning content in the Latin language. It is noted that the introduction of ICT in the educational space has expanded the possibility of studying Latin, opened access to digital libraries resources, made it possible to use scientific and educational potential and teaching Latin best practices of world's leading universities. A review of foreign and Ukrainian information resources and electronic editions for the study of Latin is given. Much attention was paid to the didactic potential of local and online multimedia courses of Latin, electronic textbooks, workbooks of interactive tests and exercises, various dictionaries and software translators, databases and digital libraries. Based on analysis of the world market of educational services and products the main trends in the development of information resources and electronic books are examined. It was found that multimedia courses with interactive exercises or workbooks with interactive tests, online dictionaries and translators are the most widely represented and demanded. The noticeable lagging of Ukrainian education and computer linguistics in quantitative and qualitative measures in this industry is established. The obvious drawback of existing Ukrainian resources and electronic editions for the study of Latin is their noninteractive nature. The prospects of e-learning content in Latin in Ukraine are outlined.

  20. Theoretical study of the interplay of electron-electron interaction and disorder

    International Nuclear Information System (INIS)

    Brezini, A.; Behilil, S.

    1988-10-01

    A disordered Hubbard model with diagonal disorder is used to investigate the electron localization effects associated with both disorder and electron-electron interaction. Extensive results are reported on the ground state properties and compared to other theories. Two regimes have been found: when the electron-electron interaction u is greater than the disorder parameter w and when u < w. (author). 18 refs, 4 figs

  1. Study of solute segregation at interfaces using Auger electron spectroscopy

    International Nuclear Information System (INIS)

    White, C.L.

    1984-01-01

    Interfacial segregation, often confined to within a few atomic distances of the interface, can strongly influence the processing and properties of metals and ceramics. The thinness of such solute-enriched regions can cause them to be particularly suitable for study using surface sensitive microanalytical techniques such as Auger electron spectroscopy (AES). The application of AES to studies of interfacial segregation in metals and ceramics is briefly reviewed, and several examples are presented. 43 references, 14 figures

  2. Positron lifetime study of electron-irradiated epoxy resins

    International Nuclear Information System (INIS)

    Suevegh, K.; Vertes, A.; Wojnarovits, L.; Foeldiak, G.; Liszkai, L.; Kajcsos, Zs.

    1990-01-01

    Two bisphenol-A type epoxy resins were irradiated by electron beam and studied afterwards by positron lifetime spectroscopy. An interesting result is that despite of the considerable amount of free-radicals, no inhibition of positronium formation was observed in the two epoxies. Nevertheless, several serious differences were detected between the studied polymers. The results suggest that the radiation-resistant properties of epoxies depend strongly on the amount of the curing agent. (author) 8 refs.; 2 figs

  3. Study of warm dense plasma electronic dynamics by optical interferometry

    International Nuclear Information System (INIS)

    Deneuville, F.

    2013-01-01

    The Warm Dense Matter (WDM) regime is characterised by a density close to the solid density and an electron temperature close to the Fermi temperature. In this work, the nonequilibrium Warm Dense Matter is studied during the solid to liquid phase transition induced by an ultra short laser interacting with a solid. A 30 femtosecond time resolution pump-probe experiment (FDI) is set up, yielding to the measurement of the heated sample complex reflectivity for both S and P polarisation. We have determined a criterion based on the measured reflectivities, which permits to control the interface shape of the probed matter. For pump laser fluences around 1 J/cm 2 , the hydrodynamics of the heated matter is studied and experimental results are compared to the two-temperatures code ESTHER. Furthermore, the evolution of the dielectric function at 800 nm and 400 nm is inferred from our measurements on a sub-picosecond time-scale. Within the Drude-Lorentz model for the conduction electrons, the dielectric function yields information such as ionisation state, electronic temperature and electron collision frequency. (author) [fr

  4. Silicon passivation study under low energy electron irradiation conditions

    International Nuclear Information System (INIS)

    Cluzel, R.

    2010-01-01

    Backside illuminated thinned CMOS (Complementary Metal Oxide Semiconductor) imaging system is a technology developed to increase the signal to noise ratio and the sensibility of such sensors. This configuration is adapted to the electrons detection from the energy range of [1 - 12 keV]. The impinging electron creates by multiplication several hundreds of secondary electrons close to the surface. A P ++ highly-doped passivation layer of the rear face is required to reduce the secondary electron surface recombination rate. Thanks to the potential barrier induced by the P ++ layer, the passivation layer increases the collected charges number and so the sensor collection gain. The goal of this study is to develop some experimental methods in order to determine the effect of six different passivation processes on the collection gain. Beforehand, the energy profile deposited by an incident electron is studied with the combination of Monte-Carlo simulations and some analytical calculations. The final collection gain model shows that the mirror effect from the passivation layer is a key factor at high energies whereas the passivation layer has to be as thin as possible at low energies. A first experimental setup which consists in irradiating P ++ /N large diodes allows to study the passivation process impacts on the surface recombinations. Thanks to a second setup based on a single event upset directly on thinned CMOS sensor, passivation techniques are discriminated in term of mirror effect and the implied spreading charges. The doping atoms activation laser annealing is turn out to be a multiplication gain inhomogeneity source impacting directly the matrix uniformity. (author)

  5. Electron and photon impact studies of CF3I

    International Nuclear Information System (INIS)

    Mason, N.J.; Eden, S.; Limao Vieire, P.; Kendall, P.; Pathak, S.; Dawes, A.; Tegeder, P.; Kitajima, M.; Okamoto, M.; Tanaka, H.; Samukawa, S.; Cho, H.; Hoffmann, S.

    2002-01-01

    The manufacture of ultra-large-scale-integrated circuits, requires a well collimated, specially uniform, high density plasma source operating under low pressure conditions. The main feed gases used are perfluorocarbons, however these are also strong greenhouse gases, therefore must be replaced by alternative compounds with low global warming potentials. CF 3 I is one possible replacement, due to its high photolysis rate, is expected to have a very short lifetime in the atmosphere. It is also predicted to be able to produced high yields of CF 3 radicals in any etching plasma, since its weak C - I bond should be possible to break by direct electron impact. Prior adapting existing industrial plasma reactors to use CF 3 I, it is necessary to run simulations of the reactant plasma, requiring a detailed database of the electron interactions with the feed gases, however such CF 3 I data does not exist. Thus an exhaustive series of experiments to measure elastic and inelastic scattering from CF 3 I including a study of its electronic state spectroscopy using photon absorption and electron scattering techniques were performed. Electron energy loss spectroscopy (EELS) and photo-absorption spectroscopy were employed. A comprehensive set of differential cross sections for the elastic scattering CF 3 I over the impact energy region from 1.5 to 60 eV for scattering angles between 20 and 130 were compiled. The photo-absorption spectrum is characterized by three regions, the first is a very weak continuum around centered about 4.7 eV; the second consists of four prominent band structures observed around 7.4, 8.1, 9.0 and 9.8 eV, respectively, containing vibrational structure from 7 to 10 eV; the third (above the ionization potentials) could only be studied by using EELS and additional broad peaks were observed. (nevyjel)

  6. Hair morphology in androgenetic alopecia: sonographic and electron microscopic studies.

    Science.gov (United States)

    Wortsman, Ximena; Guerrero, Robinson; Wortsman, Jacobo

    2014-07-01

    To assess hair morphology in androgenetic alopecia on sonography and electron microscopy. A prospective study was performed in 33 patients with androgenetic alopecia and 10 unaffected control participants. In vivo sonography of the hair follicles of the scalp and in vitro sonography and electron microscopy of the hair shafts were performed according to a standardized protocol that included analysis of the right frontal and occipital regions. The upper frequency limit of the ultrasound probes ranged between 15 and 18 MHz. Scalp hair follicles and hair shafts were recognizable on sonography in all cases. Hair follicles in alopecia cases had significantly lower depths (P alopecia also had a different distribution of their laminar pattern on in vitro sonography, with a greater presence of mixed (trilaminar and bilaminar) and solely bilaminar tracts in comparison with the controls (mostly trilaminar). On electron microscopy, the alopecia hair tracts showed irregularities and commonly a "melted candle" appearance of the cuticle. Sonography and electron microscopy uncover distinct abnormalities in the morphology of hair in androgenetic alopecia, which may potentially support the diagnosis and management of this common condition. © 2014 by the American Institute of Ultrasound in Medicine.

  7. ELECTRONIC RETAILING IN MACEDONIA-CASE STUDY OF OHRID REGION

    Directory of Open Access Journals (Sweden)

    MARGARITA JANESKA

    2017-04-01

    Full Text Available With electronic retailing that offers the possibility of direct sales, is no longer need expensive business premises, or paying high rents, or employing a number of vendors. There is also the possibility of selling to final consumers in any geographical region in different countries of the world by establishing instant communication, through presenting an interactive multimedia catalog that can offer numerous information то the customers. However, on the other hand, sales through the Internet can appear certain problems. Many potential buyers in the world still do not use the Internet, others don't have fast connections, others do not speak good English, also it requires the existence of trust between both parties, buyer and seller, as well as security in the execution of transactions. The aim of this paper is to treat electronic retailing in Macedonia which is becoming more popular as worldwide, especially in developed parts of the world like the US and Europe. Macedonian companies are increasingly applying electronic method of sale and communication with customers. The number of Internet users and on-line purchase is rapidly expanding what undoubtedly indicates that there is potential for advancement in this field. Also in this paper will be presented a case study where will be analyzed the current state for development of electronic retailing in Macedonia, especially region of Ohrid.

  8. HOSPITAL INFORMATION SYSTEMS: A STUDY OF ELECTRONIC PATIENT RECORDS

    Directory of Open Access Journals (Sweden)

    Pedro Luiz Cortês

    2011-05-01

    Full Text Available The importance of patient records, also known as medical records, is related to different needs and objectives, as they constitute permanent documents on the health of patients. With the advancement of information technologies and systems, patient records can be stored in databases, resulting in a positive impact on patient care. Based on these considerations, a research question that arises is “what are the benefits and problems that can be seen with the use of electronic versions of medical records?” This question leads to the formulation of the following hypothesis: although problems can be identified during the process of using electronic record systems, the benefits outweigh the difficulties, thereby justifying their use. To respond to the question and test the presented hypothesis, a research study was developed with users of the same electronic record system, consisting of doctors, nurses, and administrative personnel in three hospitals located in the city of São Paulo, Brazil. The results show that, despite some problems in their usage, the benefits of electronic patient records outweigh possible disadvantages.

  9. Study of the mass of the electron neutrino in Japan

    International Nuclear Information System (INIS)

    Yasumi, Shinjiro; Maezawa, Hideki

    1996-02-01

    This report describes a study of the mass of the electron neutrino using electron capture in 163 Ho in Japan for the period from 1981 to 1994. This monograph has two purposes, one is to supplement the papers on the mass of the electron neutrino already published by us and another is to make a record on some details of our experiments for future. Electron capture in a nucleus takes place in a rather small space inside an atom, where atomic physics, nuclear physics and particle physics work closely together. Therefore, this study needed an intimate collaboration of atomic physicists, nuclear physicists and particle physicists. In addition, it was necessary for this study to use various fine techniques, including metallurgy, production of 163 Ho activity, micro-analysis by wet chemistry, isotope-dilution mass spectrometry, undulator radiation source technology, the soft X-ray monochromator technology, a counting technique for very intense soft X-rays and so on. As a result, our collaboration consisted of many researchers from various fields as follows; M. Ando, H. Arai, M. Fujioka, N. Hashimoto, H. Ikeda, Y. Inagaki, K. Ishii, K. Itoh, G. Izawa, O. Kawakami, S. Kishimoto, H. Kitamura, H. Maezawa, M. Maruyama, A. Masuda, K. Masumoto, A. Mikuni, T. Mizogawa, T. Mukoyama, F. Ochiai, T. Ohta, T. Omori, G. Rajasekaran, K. Sera, K. Shima, T. Shinozuka, P.M. Stefan, I. Sugai, H. Taketani, M. Yagi, and S. Yasumi. Without such an excellent collaboration, this study would not have been completed. We would like to express our sincere gratitude to Professor T. Sasaki for supporting this study and recommending the undulator beam line of 2.5 GeV Photon Factory Storage Ring as a light source to be used in the experiment. We also would like to thank Dr. A. Yagishita and Dr. Y. Kitajima who are responsible for the BL-2 beamline. Finally we are grateful to Ms. M. Noji for her patient typewriting of manuscripts written by hand. (author)

  10. Cathodoluminescence studies of phosphors in a scanning electron microscope

    International Nuclear Information System (INIS)

    Harris, Paul; Den Engelsen, Daniel; Ireland, Terry; Fern, George; Silver, Jack

    2015-01-01

    Cathodoluminescence studies are reported of phosphors in a field emission scanning electron microscope (FESEM). A number of phosphor materials have been studied and exhibited a pronounced comet-like structure at high scan rates, because the particle continued to emit light after the beam had moved onto subsequent pixels. Image analysis has been used to study the loss of brightness along the tail and hence to determine the decay time of the materials. This technique provides a simple and convenient way to study the decay times of individual particles. (paper)

  11. Study of titanate nanotubes by X-ray and electron diffraction and electron microscopy

    Czech Academy of Sciences Publication Activity Database

    Brunátová, T.; Popelková, Daniela; Wan, W.; Oleynikov, P.; Daniš, S.; Zou, X.; Kužel, R.

    2014-01-01

    Roč. 87, January (2014), s. 166-171 ISSN 1044-5803 Institutional support: RVO:61389013 Keywords : computer simulations * transmission electron microscopy * electron diffraction Subject RIV: CD - Macromolecular Chemistry Impact factor: 1.845, year: 2014

  12. Postponed variety creation: case study in consumer electronics retail

    DEFF Research Database (Denmark)

    Appelqvist, Patrik; Gubi, Ebbe

    2005-01-01

    Purpose – Postponement is known as a way to reduce risk and inventories while still providing high product variety and acceptable response times. The paper is a case study that uses simulation for quantifying these benefits for a consumer electronics company. Design/methodology/approach – Improve...... modular product architecture can be utilised to improve operational supply chain performance.......Purpose – Postponement is known as a way to reduce risk and inventories while still providing high product variety and acceptable response times. The paper is a case study that uses simulation for quantifying these benefits for a consumer electronics company. Design....../methodology/approach – Improvement potential is first evaluated qualitatively through interviews with dealers of the case company. Next, the benefit of postponement is evaluated quantitatively using discrete-event simulation with data from operational ERP systems. The conclusions identify conditions under which postponement...

  13. Structural studies of glasses by transmission electron microscopy and electron diffraction

    International Nuclear Information System (INIS)

    Kashchieva, E.P.

    1997-01-01

    The purpose of this work is to present information about the applications of transmission electron microscopy (TEM) and electron diffraction (ED) for structural investigations of glasses. TEM investigations have been carried out on some binary and on a large number of ternary borate-telluride systems where glass-forming oxides, oxides of transitional elements and modified oxides of elements from I, II and III groups in the periodic table, are used as third component. The large experimental data given by TEM method allows the fine classification of the micro-heterogeneities. A special case of micro-heterogeneous structure with technological origin occurs near the boundary between the 2 immiscible liquids obtained at macro-phase separation. TEM was also used for the direct observation of the glass structure and we have studied the nano-scale structure of borate glasses obtained at slow and fast cooling of the melts. The ED possesses advantages for analysis of amorphous thin films or micro-pastilles and it is a very useful technique for study in materials containing simultaneously light and heavy elements. A comparison between the possibilities of the 3 diffraction techniques (X-ray diffraction, neutron diffraction and ED) is presented

  14. Interlayer magnetotransport study in electron-doped Sm2 ...

    Indian Academy of Sciences (India)

    along the c-axis, ρc(T) shows a parallel shift without significant broadening, as also ob- served in the ... Tc cuprates has been used as a powerful probe for both the density of states in the CuO2 planes [2,3], as well as ... Recent normal-state studies in electron-doped systems indicate that the two sides of the doping divide in ...

  15. Electron paramagnetic resonance study on n-type electron-irradiated 3C-SiC

    Energy Technology Data Exchange (ETDEWEB)

    Carlsson, P; Rabia, K; Son, N T; Janzen, E [Department of Physics, Chemistry and Biology, Linkoeping University, SE-581 83 Linkoeping (Sweden); Ohshima, T; Morishita, N; Itoh, H [Japan Atomic Energy Research Institute, Takasaki 370-1292 (Japan); Isoya, J [University of Tsukuba, Tsukuba 305-8550 (Japan)], E-mail: paca@ifm.liu.se

    2008-03-15

    Electron Paramagnetic Resonance (EPR) was used to study defects in n-type 3C-SiC films irradiated by 3-MeV electrons at room temperature with a dose of 2x10{sup 18} cm{sup -2}. After electron irradiation, two new EPR spectra with an effective spin S = 1, labeled L5 and L6, were observed. The L5 center has C{sub 3v} symmetry with g = 2.004 and a fine-structure parameter D = 436.5x10{sup -4} cm{sup -1}. The L5 spectrum was only detected under light illumination and it could not be detected after annealing at {approx}550{sup 0}C. The principal z-axis of the D tensor is parallel to the <111>-directions, indicating the location of spins along the Si-C bonds. Judging from the symmetry and the fact that the signal was detected under illumination in n-type material, the L5 center may be related to the divacancy in the neutral charge state. The L6 center has a C{sub 2v}-symmetry with an isotropic g-value of g = 2.003 and the fine structure parameters D = 547.7x10{sup -4} cm{sup -1} and E = 56.2x10{sup -4} cm{sup -1}. The L6 center disappeared after annealing at a rather low temperature ({approx}200 deg. C), which is substantially lower than the known annealing temperatures for vacancy-related defects in 3C-SiC. This highly mobile defect may be related to carbon interstitials.

  16. Transmission Electron Microscopy Studies of Electron-Selective Titanium Oxide Contacts in Silicon Solar Cells

    KAUST Repository

    Ali, Haider

    2017-08-15

    In this study, the cross-section of electron-selective titanium oxide (TiO2) contacts for n-type crystalline silicon solar cells were investigated by transmission electron microscopy. It was revealed that the excellent cell efficiency of 21.6% obtained on n-type cells, featuring SiO2/TiO2/Al rear contacts and after forming gas annealing (FGA) at 350°C, is due to strong surface passivation of SiO2/TiO2 stack as well as low contact resistivity at the Si/SiO2/TiO2 heterojunction. This can be attributed to the transformation of amorphous TiO2 to a conducting TiO2-x phase. Conversely, the low efficiency (9.8%) obtained on cells featuring an a-Si:H/TiO2/Al rear contact is due to severe degradation of passivation of the a-Si:H upon FGA.

  17. Electronic Document Management: A Human Resource Management Case Study

    Directory of Open Access Journals (Sweden)

    Thomas Groenewald

    2004-11-01

    Full Text Available This case study serve as exemplar regarding what can go wrong with the implementation of an electronic document management system. Knowledge agility and knowledge as capital, is outlined against the backdrop of the information society and knowledge economy. The importance of electronic document management and control is sketched thereafter. The literature review is concluded with the impact of human resource management on knowledge agility, which includes references to the learning organisation and complexity theory. The intervention methodology, comprising three phases, follows next. The results of the three phases are presented thereafter. Partial success has been achieved with improving the human efficacy of electronic document management, however the client opted to discontinue the system in use. Opsomming Die gevalle studie dien as voorbeeld van wat kan verkeerd loop met die implementering van ’n elektroniese dokumentbestuur sisteem. Teen die agtergrond van die inligtingsgemeenskap en kennishuishouding word kennissoepelheid en kennis as kapitaal bespreek. Die literatuurstudie word afgesluit met die inpak van menslikehulpbronbestuur op kennissoepelheid, wat ook die verwysings na die leerorganisasie en kompleksietydsteorie insluit. Die metodologie van die intervensie, wat uit drie fases bestaan, volg daarna. Die resultate van die drie fases word vervolgens aangebied. Slegs gedeelte welslae is behaal met die verbetering van die menslike doeltreffendheid ten opsigte van elektroniese dokumentbestuur. Die klient besluit egter om nie voort te gaan om die huidige sisteem te gebruik nie.

  18. Microscopical Studies of Structural and Electronic Properties of Semiconductors

    CERN Multimedia

    2002-01-01

    The electronic and structural properties of point defects in semiconductors, e.g. radiation defects, impurities or passivating defects can excellently be studied by the hyperfine technique of Perturbed Angular Correlation (PAC). The serious limitation of this method, the small number of chemically different radioactive PAC probe atoms can be widely overcome by means of ISOLDE. Providing shortliving isotopes, which represent common dopants as well as suitable PAC probe atoms, the ISOLDE facility enables a much broader application of PAC to problems in semiconductor physics.\\\\ Using the probe atom $^{111m}$ Cd , the whole class of III-V compounds becomes accessible for PAC investigations. First successful experiments in GaAs, InP and GaP have been performed, concerning impurity complex formation and plasma induced defects. In Si and Ge, the electronic properties~-~especially their influence on acceptor-donor interaction~-~could be exemplarily st...

  19. Dissociative electron attachment, electron transmission, and electron energy-loss study of the temporary negative ion of acetylene

    International Nuclear Information System (INIS)

    Dressler, R.; Allan, M.

    1987-01-01

    The three title electron-impact techniques are used to study the ground and excited states of acetylene negative ion and their decay processes. The π* resonance at 2.6 eV predissociates into C 2 H - and H. Four narrow resonances are observed in the transmission spectrum in the 7.5--9.5 eV region and assigned to Feshbach and core-excited shape resonances with double occupation of Rydberg orbitals and ground state positive ion core. These four resonances decay into low-lying Rydberg states of neutral acetylene, the first two undergo quasiresonant autodetachment ejecting low energy ( - 2 . One additional resonance is observed in the C - 2 yield, which is not observable in other decay channels. The shapes of the dissociative attachment bands differ qualitatively from the band shapes of the parent and grandparent states, indicating either a strong v dependence of the dissociation rate or the admixture of σ* orbitals in some of the dissociating anion states

  20. A study on the secondary electrons in a clinical electron beam

    International Nuclear Information System (INIS)

    Krithivas, G.; Rao, S.N.

    1989-01-01

    The central axis dose of a 12 MeV clinical electron beam is investigated in terms of an axial component due to primary electrons in the central ray and a lateral component due to secondary electrons originating from multiple scattering of electrons in the off-axis rays. To this effect secondary electron fluence measurements in a polystyrene medium irradiated with a collimated beam are made with a sensitive diode detector. This leads to a construction of secondary electron depth-dose profiles for beam sizes of diameters ranging from 1.7 to 17.4 cm. The results indicate that the lateral electrons account for 25% of the dose in the therapeutic region. For these electrons, the depth of dose maximum is correlated with diffusion depth and maximum lateral excursion in the medium. Dose component due to backscatter electrons at depths is also investigated using a thin-window parallel-plate ion chamber. The role of lateral and backscatter electrons in characterising central axis per cent depth-dose is discussed. (author)

  1. Modified Monte Carlo method for study of electron transport in degenerate electron gas in the presence of electron–electron interactions, application to graphene

    Energy Technology Data Exchange (ETDEWEB)

    Borowik, Piotr, E-mail: pborow@poczta.onet.pl [Warsaw University of Technology, Faculty of Physics, ul. Koszykowa 75, 00-662 Warszawa (Poland); Thobel, Jean-Luc, E-mail: jean-luc.thobel@iemn.univ-lille1.fr [Institut d' Electronique, de Microélectronique et de Nanotechnologies, UMR CNRS 8520, Université Lille 1, Avenue Poincaré, CS 60069, 59652 Villeneuve d' Ascq Cédex (France); Adamowicz, Leszek, E-mail: adamo@if.pw.edu.pl [Warsaw University of Technology, Faculty of Physics, ul. Koszykowa 75, 00-662 Warszawa (Poland)

    2017-07-15

    Standard computational methods used to take account of the Pauli Exclusion Principle into Monte Carlo (MC) simulations of electron transport in semiconductors may give unphysical results in low field regime, where obtained electron distribution function takes values exceeding unity. Modified algorithms were already proposed and allow to correctly account for electron scattering on phonons or impurities. Present paper extends this approach and proposes improved simulation scheme allowing including Pauli exclusion principle for electron–electron (e–e) scattering into MC simulations. Simulations with significantly reduced computational cost recreate correct values of the electron distribution function. Proposed algorithm is applied to study transport properties of degenerate electrons in graphene with e–e interactions. This required adapting the treatment of e–e scattering in the case of linear band dispersion relation. Hence, this part of the simulation algorithm is described in details.

  2. MUNU: study of the neutrino-electron scattering; MUNU: etude de la diffusion neutrino-electron

    Energy Technology Data Exchange (ETDEWEB)

    Cerna, C

    2000-11-01

    MUNU is an experiment dedicated to electron-neutrino scattering studies and in particular to neutrino magnetic moment search at a nuclear power plant in Bugey (France). MUNU is based on a gaseous time projection chamber (TPC) immersed in 8 tons of liquid scintillator acting as an active anti-Compton shielding. A preliminary analysis of the first results of this experiment corresponding to about 24 days of data collecting draws a line on the value of the neutrino magnetic moment: {mu}{sub {nu}}-bar{sub {sub e}} {<=} 1.97 10{sup -10} {mu}{sub B} (68% confidence level). All along this work, it is shown that the combined use of a TPC and of a light detection system is valuable for discriminating particles and for discarding signals from background noise.

  3. Electron Paramagnetic Resonance studies of x-ray irradiated Nafion

    Science.gov (United States)

    Fragoso, Juan; Usher, Timothy

    2007-03-01

    Fuel cells promise a bright future as power sources for a variety of electronic equipment as well as more power demanding elements. Nafion (DuPont's trademark of a sulfonated tetrafluorethylene polymer modified from Teflon) is the heart of Proton Exchange Membrane Fuel Cells (PEMFCs) as well as Direct Methanol Fuel Cells (DMFCs). Fuel cells are used to power electronic equipment on spacecraft, satellites and unpiloted high altitude aircraft, where ionizing radiation can be a concern. Electron Paramagnetic Resonance (EPR) is a spectroscopic technique that is very sensitive to free radicals such as those produced by ionizing radiation therefore EPR can give us a window into the degradation of the Nafion membranes due to the ionizing radiation. Nafion samples were irradiated using a x-ray diffractometer with a copper target operating at 40kV and 55mA for at least 3hrs. X-Band EPR spectroscopy of the irradiated nafion reveals a peak at 3400G with a width of 10G, which decays over time, completely diminishing in a couple of weeks. Preliminary results from the polarization studies on the effects of ionizing radiation will also be presented.

  4. Electron microscopy--new tool for service failure study

    Energy Technology Data Exchange (ETDEWEB)

    Warke, W.R.; McCall, J.L.

    1965-05-01

    Electron microscopy, now well established as a research tool for the study of metal fractures, can be valuable for analyzing service failures. The high magnifications of electron microscopes, ranging from 500 to 200,000 X, coupled with their large vertical resolution, make it possible to distinguish overload failures from fatigue failures from brittle intergranular failures, and so on. Generally speaking, 2 basic techniques are used to replicate fractured surfaces. They the direct carbon method and the 2-stage plastic carbon technique. Each has its limitations and specific areas of application. Direct carbon eliminates an intermediate step; it thus gives a higher fidelity replica and allows extraction of inclusions and precipitates, but destroys the sample. The plastic carbon replica is nondestructive, but less faithful in reproducing the finest features of the surface. For this reason, the direct method is used primarily for fundamental research, while the plastic carbon technique is used when specimen availability is a problem or service failures are to be analyzed. The applicability of electron microscopy to service failure analyses is illustrated by 3 examples.

  5. High Resolution Studies of Electron Attachment to Molecules

    International Nuclear Information System (INIS)

    Braun, M.; Ruf, M.-W.; Hotop, H.; Fabrikant, I. I.

    2009-01-01

    In this paper, we survey recent progress in studies of anion formation via (dissociative) electron attachment (DEA) to simple molecules, as measured with the laser photoelectron attachment (LPA) method at high resolution. The limiting (E→0) threshold behavior of the cross sections is elucidated for s-wave and p-wave attachment. Cusps at onsets for vibrational excitation (VE), due to interaction of the DEA channnel with the VE channel, are clearly detected, and vibrational Feshbach resonances just below vibrational onsets are observed for molecules with sufficiently strong long-range attraction between the electron and the molecule. From the LPA anion yields, absolute DEA cross sections (energy range typically E = 0.001-2 eV) are determined with reference to rate coefficients for thermal electron attachment at the appropriate gas temperature (normally T G = 300 K). The experimental data are compared with theoretical cross sections, calculated within the framework of an R-matrix or an Effective Range theory approach.

  6. Study of Electron Beam Curing Process Using Epoxy Resin System

    International Nuclear Information System (INIS)

    Nishitsuji, D. A.

    2006-01-01

    The competition among industries in the current globalization system has required a systematic cost reduction without affecting the quality of the final product. This fact has encouraged the use of new technologies application on productive process, especially on polymeric composites, to assure the competitiveness. The possibility of producing a new type of carbon fiber reinforced composite by radiation process with excellent thermal and mechanical properties, has been researched since 90's and it can be a potential application in aerospace, marine and automobile industries. The polymeric composites cured by thermal process (furnace or autoclave) are an example of long curing cycles, which requires time and energy consumption. Electron beam curing technology allows the process at room temperature and reduces curing time; consequently, it becomes the main difference of this technology over thermal curing process. The aim of this work was to study electron beam curable epoxy formulation for filament winding process, as well as to investigate the electron beam curing process parameters using a DC 1500/25 - Job 188 Dynamitron model linear accelerator as radiation source, with 0.5 to 1.5 MeV, 0.1 to 25 mA and 60 to 120 cm scanning electron beam. The resin system consists of commercial epoxy resin (diglycidyl ether of bisphenol A - DGEBA) and cationic initiator (diaryliodonium hexafluoantimonate) and the polymerization carried out at room temperature with controlled dose rate. Thermal post cure took part of the process to improve the degree of cure and glass transition temperature (Tg) similar to thermal curable resin properties

  7. Study of the mass of the electron neutrino in Japan

    Energy Technology Data Exchange (ETDEWEB)

    Yasumi, Shinjiro; Maezawa, Hideki [eds.

    1996-02-01

    This report describes a study of the mass of the electron neutrino using electron capture in {sup 163}Ho in Japan for the period from 1981 to 1994. This monograph has two purposes, one is to supplement the papers on the mass of the electron neutrino already published by us and another is to make a record on some details of our experiments for future. Electron capture in a nucleus takes place in a rather small space inside an atom, where atomic physics, nuclear physics and particle physics work closely together. Therefore, this study needed an intimate collaboration of atomic physicists, nuclear physicists and particle physicists. In addition, it was necessary for this study to use various fine techniques, including metallurgy, production of {sup 163}Ho activity, micro-analysis by wet chemistry, isotope-dilution mass spectrometry, undulator radiation source technology, the soft X-ray monochromator technology, a counting technique for very intense soft X-rays and so on. As a result, our collaboration consisted of many researchers from various fields as follows; M. Ando, H. Arai, M. Fujioka, N. Hashimoto, H. Ikeda, Y. Inagaki, K. Ishii, K. Itoh, G. Izawa, O. Kawakami, S. Kishimoto, H. Kitamura, H. Maezawa, M. Maruyama, A. Masuda, K. Masumoto, A. Mikuni, T. Mizogawa, T. Mukoyama, F. Ochiai, T. Ohta, T. Omori, G. Rajasekaran, K. Sera, K. Shima, T. Shinozuka, P.M. Stefan, I. Sugai, H. Taketani, M. Yagi, and S. Yasumi. Without such an excellent collaboration, this study would not have been completed. We would like to express our sincere gratitude to Professor T. Sasaki for supporting this study and recommending the undulator beam line of 2.5 GeV Photon Factory Storage Ring as a light source to be used in the experiment. We also would like to thank Dr. A. Yagishita and Dr. Y. Kitajima who are responsible for the BL-2 beamline. Finally we are grateful to Ms. M. Noji for her patient typewriting of manuscripts written by hand. (author).

  8. Color formation study of irradiated polymers by electron beam

    International Nuclear Information System (INIS)

    Nardi, Daniela Teves

    2004-01-01

    Color formation on national and commercial polymers (polymethyl methacrylate, polystyrene and polycarbonate) irradiated by electrons beam was investigated by colorimetry (CIELab), electron spectroscopy resonance (ESR), photoacoustic infrared spectroscopy (FTIR-PAS) and differential exploratory calorimetry (DSC). The heat effect on colorimetric properties was investigated after heating (110 deg C for 1 hour) of irradiated polymers at 150 kGy. The rule of oxygen in colorimetric properties of irradiated polycarbonate was investigated in the air presence and absence (p = 10 -3 mmHg). The visual aspect did not agree with colorimetric parameters only for polycarbonate. Yellow color and darkness were induced by radiation for all studied polymers varying only the intensity and behavior in function of post-irradiation time and heating. Polymethyl methacrylate and polystyrene ESR spectra showed that radicals could be responsible by yellow color centers. Wherever, in polycarbonate, color centers were not due radical species. The nature of color centers for any studied polymer was not study by FTIR-PAS because there were no changes in FTIR-PAS spectra neither in function of dose nor heating. Polycarbonate was the most radiosensible and polystyrene was the most radioresistant of all studied polymers in concern of colorimetric properties. (author)

  9. A comparative study of electronic stethoscopes for cardiac auscultation.

    Science.gov (United States)

    Pinto, C; Pereira, D; Ferreira-Coimbra, J; Portugues, J; Gama, V; Coimbra, M

    2017-07-01

    There are several electronic stethoscopes available on the market today, with a very high potential for healthcare namely telemedicine, assisted decision and education. However, there are no recent comparatives studies published about the recording quality of auscultation sounds. In this study we aim to: a) define a ranking, according to experts opinion of 6 of the most relevant electronic stethoscopes on the market today; b) verify if there are any relations between a stethoscope's performance and the type of pathology present; c) analyze if some pathologies are more easily identified than others when using electronic auscultation. Our methodology consisted in creating two study groups: the first group included 18 cardiologists and cardiology house officers, acting as the gold standard of this work. The second included 30 medical students. Using a database of heart sounds recorded in real hospital environments, we applied questionnaires to observers from each group. The first group listened to 60 cardiac auscultations recorded by the 6 stethoscopes, and each one was asked to identify the pathological sound present: aortic stenosis, mitral regurgitation or normal. The second group was asked to choose, between two auscultation recordings, using as criteria the best sound quality for the identification of pathological sounds. Results include a total of 1080 evaluations, in which 72% of cases were correctly diagnosed. A detailed breakdown of these results is presented in this paper. As conclusions, results showed that the impact of the differences between stethoscopes is very small, given that we did not find statistically significant differences between all pairs of stethoscopes. Normal sounds showed to be easier to identify than pathological sounds, but we did not find differences between stethoscopes in this identification.

  10. Interfacial Electron Transfer and Transient Photoconductivity Studied with Terahertz Spectroscopy

    Science.gov (United States)

    Milot, Rebecca Lee

    Terahertz spectroscopy is distinguished from other far infrared and millimeter wave spectroscopies by its inherent phase sensitivity and sub-picosecond time resolution making it a versatile technique to study a wide range of physical phenomena. As THz spectroscopy is still a relatively new field, many aspects of THz generation mechanisms have not been fully examined. Using terahertz emission spectroscopy (TES), THz emission from ZnTe(110) was analyzed and found to be limited by two-photon absorption and free-carrier generation at high excitation fluences. Due to concerns about the continued use of fossil fuels, solar energy has been widely investigated as a promising source of renewable energy. Dye-sensitized solar cells (DSSCs) have been developed as a low-cost alternative to conventional photovoltaic solar cells. To solve the issues of the intermittency and inefficient transport associated with solar energy, researchers are attempting to adapt DSSCs for water oxidation and chemical fuel production. Both device designs incorporate sensitizer molecules covalently bound to metal oxide nanoparticles. The sensitizer, which is comprised of a chromophore and anchoring group, absorbs light and transfers an electron from its excited state to the conduction band of the metal oxide, producing an electric current. Using time-resolved THz spectroscopy (TRTS), an optical pump/THz probe technique, the efficiency and dynamics of electron injection from sensitizers to metal oxides was evaluated as a function of the chromophore, its anchoring group, and the metal oxide identity. Experiments for studying fully functioning DSSCs and water oxidation devices are also described. Bio-inspired pentafluorophenyl porphyrin chromophores have been designed and synthesized for use in photoelectrochemical water oxidation cells. Influences on the efficiency and dynamics of electron injection from the chromophores into TiO2 and SnO2 nanoparticles due to changes in both the central substituent to

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

    Science.gov (United States)

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

    2017-01-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.”1 The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole‐body framework.2 PMID:28571121

  12. Electron-electron luminosity in the Next Linear Collider -- a preliminary study

    International Nuclear Information System (INIS)

    Zimmermann, F.; Thompson, K.A.; Helm, R.H.

    1997-11-01

    In this paper, the authors discuss some operational aspects of electron-electron collisions at the Next Linear Collider (NLC) and estimate the luminosity attainable in such a machine. They also consider the use of two future technologies which could simplify the operation and improve the luminosity in an e - e - collider: polarized rf guns and plasma lenses

  13. Studies of electron correlation in the photoionization process

    Energy Technology Data Exchange (ETDEWEB)

    Rosenberg, Richard Allen [Univ. of California, Berkeley, CA (United States)

    1979-03-01

    Electron correlation is a result of the interaction of two or more electrons confined in a region of space, and may conveniently be treated under the formalism of configuration interaction (CI). Photoionization provides a rather direct experimental method for studying configuration interaction. The types of CI involved in the photoionization process can be divided into three categories: initial state configuration interaction (ISCI), final ionic state configuration interaction (FISCI), and continuum state configuration interaction (CSCI). This thesis deals with experimental studies which reveal how the various types of CI may become manifested in photoionization. The experimental methods utilized in this work are photoelectron spectroscopy (PES), electron impact spectroscopy (EIS), and time-resolved fluorescence spectroscopy. The EIS was carried out following the discovery that the UV lamp on a Perkin-Elmer photoelectron spectrometer could be utilized as a source of low energy electrons. The time-resolved fluorescence work utilized both the tunability and the time structure of the radiation available at the Stanford Synchrotron Radiation Laboratory (SSRL). A commercial photoelectron spectrometer equipped with a conventional UV lamp (Hei, Nei) was employed for some of the PES studies, and a novel time-of-flight photoelectron spectrometer was developed for the PES work performed using synchrotron radiation. The PES of Ba, Sm, Eu, and Yb was studied using both Hei (22.22 eV) and Nei (16.85 eV) radiation. Satellite structure observed in these spectra using Nei (and for Yb, Hei also) radiation could be satisfactorily explained by ISCI alone. The Hei spectra of Sm, Eu, and, in particular, Ba showed dramatic changes in the satellite population which could only be explained by a new mechanism, autoionization, which is a special form of CSCI. The detailed nature of this mechanism was explored in Ba using synchrotron radiation. It was found that the autoionizing level decays

  14. Studies of the longitudinal instability with an electron beam

    International Nuclear Information System (INIS)

    1993-01-01

    Goals for our first-year period are as follows: To study the evolution of a small perturbation in the current pulse (introduced via the grid voltage on the electron gun) when the beam propagates through our 5-m long periodic solenoid channel. Specifically, to see if the perturbation is reflected from the rear end of the pulse. So far these objectives have been met without any delays. We were able to launch different perturbations on the beam resulting in either a slow space-charge wave or a fast wave or both waves. The relative strength of each wave was found to depend on the electron emission temperature of the cathode. The propagation of these waves on an initially rectangular longitudinal beam profile was measured with fast current monitors and the kinetic energy was measured with sensitive energy analyzers at various positions along the 5-m long solenoidal focusing channel. We have also begun to study the behavior of the waves when they reach the respective edge of the beam. But this work is still of a preliminary nature, and we need to refine the beam conditions and measurements in future studies to reach any firm conclusions. Preparations for the resistive-wall instability experiment are in progress

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

    Science.gov (United States)

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

    2016-03-01

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

  16. Microstructural studies of dental amalgams using analytical transmission electron microscopy

    Science.gov (United States)

    Hooghan, Tejpal Kaur

    Dental amalgams have been used for centuries as major restorative materials for decaying teeth. Amalgams are prepared by mixing alloy particles which contain Ag, Sn, and Cu as the major constituent elements with liquid Hg. The study of microstructure is essential in understanding the setting reactions and improving the properties of amalgams. Until the work reported in this dissertation, optical microscopy (OM), scanning electron microscopy (SEM), and x-ray diffractometry (XRD) were used commonly to analyze amalgam microstructures. No previous systematic transmission electron microscopy (TEM) study has been performed due to sample preparation difficulties and composite structure of dental amalgams. The goal of this research was to carry out detailed microstructural and compositional studies of dental amalgams. This was accomplished using the enhanced spatial resolution of the TEM and its associated microanalytical techniques, namely, scanning transmission electron microscopy (STEM), x-ray energy dispersive spectroscopy (XEDS) and micro-microdiffraction (mumuD). A new method was developed for thinning amalgam samples to electron transparency using the "wedge technique." Velvalloy, a low-Cu amalgam, and Tytin, a high-Cu amalgam, were the two amalgams characterized. Velvalloy is composed of a Agsb2Hgsb3\\ (gammasb1)/HgSnsb{7-9}\\ (gammasb2) matrix surrounding unreacted Agsb3Sn (gamma) particles. In addition, hitherto uncharacterized reaction layers between Agsb3Sn(gamma)/Agsb2Hgsb3\\ (gammasb2)\\ and\\ Agsb2Hgsb3\\ (gammasb1)/HgSnsb{7-9}\\ (gammasb2) were observed and analyzed. An Ag-Hg-Sn (betasb1) phase was clearly identified for the first time. In Tytin, the matrix consists of Agsb2Hgsb3\\ (gammasb1) grains. Fine precipitates of Cusb6Snsb5\\ (etasp') are embedded inside the gammasb1 and at the grain boundaries. These precipitates are responsible for the improved creep resistance of Tytin compared to Velvalloy. The additional Cu has completely eliminated the gammasb

  17. A Comparative Study of Gold Bonding via Electronic Spectroscopy

    Science.gov (United States)

    Zhang, Ruohan

    The bonding and electrostatic properties of gold containing molecules are highly influenced by relativistic effects. To understand this facet on bonding, a series of simple diatomic AuX (X=F, Cl, O and S) molecules, where upon bond formation the Au atom donates or accepts electrons, was investigated and discussed in this thesis. First, the optical field-free, Stark, and Zeeman spectroscopic studies have been performed on AuF and AuCl. The simple polar bonds between Au and typical halogens (i.e. F and Cl) can be well characterized by the electronic structure studies and the permanent electric dipole moments, mu el. The spectroscopic parameters have been precisely determined for the [17.7]1, [17.8]0+ and X1Sigma + states of AuF, and the [17.07]1, [17.20]0+ and X1Sigma+ states of AuCl. The mu el have been determined for ground and excited states of AuF and AuCl. The results from the hyperfine analysis and Stark measurement support the assignments that the [17.7]1 and [17.8]0+ states of AuF are the components of a 3pi state. Similarly, the analysis demonstrated the [19.07]1 and [19.20]0+ states are the components of the 3pi state of AuCl. Second, my study focused on AuO and AuS because the bonding between gold and sulfur/oxygen is a key component to numerous established and emerging technologies that have applications as far ranging as medical imaging, catalysis, electronics, and material science. The high-resolution spectra were record and analyzed to obtain the geometric and electronic structural data for the ground and excited states. The electric dipole moment, muel , and the magnetic dipole moment, mum, has been the precisely measured by applying external static electric and magnetic fields. muel and mum are used to give insight into the unusual complex bonding in these molecules. In addition to direct studies on the gold-containing molecules, other studies of related molecules are included here as well. These works contain the pure rotation measurement of Pt

  18. Study on local vacuum electron beam welding of flange rim

    CERN Document Server

    He Cheng Dan; Ying Lei; Xu Qi Jin

    2002-01-01

    Local vacuum electron beam welding and its application prospect in military and civil industry are introduced. A home made local vacuum electron beam welding is completed. Its main technical parameters and key techniques are also presented

  19. A method to study electron heating during ICRH

    International Nuclear Information System (INIS)

    Eriksson, L.G.; Hellsten, T.

    1989-01-01

    Collisionless absorption of ICRF waves occurs either by ion cyclotron absorption or by electron Landau (ELD) and transit damping (TTMP). Both ion cyclotron absorption, and direct electron absorption results in electron heating. Electron heating by minority ions occurs after a high energy tail of the resonating ions has been formed i.e. typically after 0.2-1s in present JET experiments. Electron heating through ELD, and TTMP, takes place on the timescale given by electron-electron collisions which is typically of the order of ms. This difference in the timescales can be used to separate the two damping mechanisms. This can be done by measuring the time derivatives of the electron temperature after sawtooth crashes during ramp-up and ramp-down of the RF-power. (author) 4 refs., 4 figs

  20. Electron microscopy study of advanced heterostructures for optoelectronics

    Energy Technology Data Exchange (ETDEWEB)

    Katcki, J.; Ratajczak, J.; Phillipp, F.; Muszalski, J.; Bugajski, M.; Chen, J.X.; Fiore, A

    2003-08-28

    The application of cross-sectional transmission electron microscopy and scanning electron microscopy to the investigation of optoelectronic devices are reviewed. Special attention was paid to the electron microscopy assessment of the growth perfection of such crucial elements of the devices like quantum wells, quantum dots, distributed Bragg reflectors as well as electrical contacts. Using these examples, the most important issues of the application of electron microscopy to characterization of optoelectronic devices are discussed.

  1. Study and realization of an electron gun at low energy

    International Nuclear Information System (INIS)

    Camus, P.

    1977-01-01

    This work presents the theoretical concepts and experimental design of an electron gun. This gun is working in the weak energy range and the focus position is independant of electron energy measurements and analysis methods of the electron beam are described [fr

  2. An explanatory study on electronic commerce for reverse logistics.

    NARCIS (Netherlands)

    A.I. Kokkinaki; R. Dekker (Rommert); J.A.E.E. van Nunen (Jo); C.P. Pappis (Costas)

    1999-01-01

    textabstractIn this paper we consider the role Electronic Commerce plays and can play for Reverse Logistics. After short introductions to electronic commerce and reverse logistics, we give an overview of existing internet sites for reverse logistics. These sites can be classified as electronic

  3. Electrical and Electronical Waste Generation in Turkey: Bursa Case Study

    Directory of Open Access Journals (Sweden)

    Güray SALİHOĞLU

    2016-10-01

    Full Text Available Electrical and electronical equipment that gradually take more place in our daily life, spend their service life in short times and become an e-waste problem to be solved.  Because of the hazardous components they contain, e-waste can cause environmental and human health threats if they are not properly managed. If they are managed properly, they can be a valuable raw material source, since they contain valuable metals such as copper, silver, gold, palladium and recyclable components such as plastics and metals. According to a research conducted in 2014, the global e-waste amount accounts to a source worth 52 billion $; however, only 16% of this source has been properly recycled. It is important to know the potential e-waste amount and the behaviors of people in the production of e-waste to realize a proper e-waste management in our country. The amount and property of electrical and electronic equipment and e-waste generation potential per person in Bursa was investigated in this study. A questionnaire was prepared and applied to a group of people including 31 families (100 person. The questions were to investigate the behaviors in the use, replacement, and management of electrical and electronical equipment. The findings showed that usage of lamps (fluorescent and others were higher than the other equipment, and usage of mobile phones were found to be highest in terms of devices. It was also found that when the mobiles become e-waste since the owners do not want to use them, they are not just thrown away and kept at homes instead. E-waste generation potential of a person from the families investigated was estimated to be 8.14 kg/year.

  4. Reflection High Energy Electron Diffraction Studies of Interface Formation.

    Science.gov (United States)

    Pukite, Paul

    1988-12-01

    The epitaxial growth of semiconductors, such as GaAs, by the technique of molecular beam epitaxy (MBE) has led to many improvements in device performance and capabilities. One important system is the epitaxial growth of GaAs on Si. This holds great promise for integrating optical and electronic devices on the same chip. The key to achieving this is to grow high quality GaAs layers on Si substrates. In this investigation, single-crystal GaAs was grown on Si and Ge substrates by MBE. The growth of the epitaxial layers was investigated in situ with reflection high-energy electron diffraction (RHEED). Important in this heteroepitaxial system is that two possible GaAs crystal orientations can be obtained. By using a theory of kinematic electron diffraction developed in the course of this work, the mechanisms and growth conditions which choose between the two GaAs orientations have been determined for the first time. A further result is that the epitaxial growth processes are anisotropic on the two orientations. This leads to different crystalline qualities dependent on the orientation. To understand this in more detail, the crystal growth process was formulated mathematically. By incorporating the concepts of anisotropic diffusion and adsorption into a nonlinear differential equation, the time-dependent growth and RHEED behavior has been calculated and compared to experiment. The experimental observations of RHEED intensity oscillations and two-dimensional clustering are in excellent agreement with the diffraction and growth theories. It is concluded that surface steps play a vital role in the crystal growth and interface formation processes reported in this study.

  5. Design studies for the electron storage ring EUTERPE

    International Nuclear Information System (INIS)

    Xi Boling.

    1995-01-01

    The 400 MeV electron storage ring EUTERPE is under construction at Eindhoven University of Technology. The ring is to be used as an experimental tool for accelerator physics studies and synchroton radiation applications. The main task of the current research work is the electron optical design of the ring. Lattice design is a basis for machine design as a whole. Design aspects regarding the basic lattice, based on single particle dynamics, include determination of the equilibrium beam size and bunch length, design of achromatic bending sections, selection of tune values, correction of chromaticity, and minimization of the natural emittance in the ring. The basic lattice designed for the EUTERPE ring has a high flexibility so that different electron optical modes can be realized easily. In low energy storage rings with a high beam current, collective effects can cause a significant change in the bunch length, the transverse emittance and the beam lifetime. In order to ensure a good optical performance for the ring, the choice of suitable parameters concerning the vacuum and RF system are essential as far as collective effects are concerned. An estimation of the collective effects in the ring is given. The injector for EUTERPE is a 75 MeV racetrack microtron which is injected from a 10 MeV linac. In order to get sufficient beam current in the ring, a special procedure of continuous injection with an adjustable locally shifted closed orbit has been presented. Details of the injection procedure and numerical simulations are given. (orig./HSI)

  6. Design studies for the electron storage ring EUTERPE

    Energy Technology Data Exchange (ETDEWEB)

    Xi Boling

    1995-05-18

    The 400 MeV electron storage ring EUTERPE is under construction at Eindhoven University of Technology. The ring is to be used as an experimental tool for accelerator physics studies and synchroton radiation applications. The main task of the current research work is the electron optical design of the ring. Lattice design is a basis for machine design as a whole. Design aspects regarding the basic lattice, based on single particle dynamics, include determination of the equilibrium beam size and bunch length, design of achromatic bending sections, selection of tune values, correction of chromaticity, and minimization of the natural emittance in the ring. The basic lattice designed for the EUTERPE ring has a high flexibility so that different electron optical modes can be realized easily. In low energy storage rings with a high beam current, collective effects can cause a significant change in the bunch length, the transverse emittance and the beam lifetime. In order to ensure a good optical performance for the ring, the choice of suitable parameters concerning the vacuum and RF system are essential as far as collective effects are concerned. An estimation of the collective effects in the ring is given. The injector for EUTERPE is a 75 MeV racetrack microtron which is injected from a 10 MeV linac. In order to get sufficient beam current in the ring, a special procedure of continuous injection with an adjustable locally shifted closed orbit has been presented. Details of the injection procedure and numerical simulations are given. (orig./HSI).

  7. Volumetric Studies of Earth's Electron Foreshock Using PEACE Data

    Science.gov (United States)

    Goldstein, Melvyn L.; Gurgiolo, Chris; Fazakersley, Andrew

    2010-01-01

    We describe the methodology used to set up and compute spatial derivatives of the electron moments using data acquired by the Plasma Electron And Current Experiment (PEACE) electron data from the four Cluster spacecraft. The results are used to investigate electron vorticity in the foreshock. What is found is that much of the measured vorticity, under nominal conditions, appears to be caused by changes in the flow direction of the return (either reflected or leakage from the magnetosheath) and strahl electron populations as they couple to changes in the magnetic field orientation. This in turn results in deflections in the total bulk velocity.

  8. Electron spin resonance intercomparison studies on irradiated foodstuffs

    International Nuclear Information System (INIS)

    Raffi, J.

    1992-01-01

    The results of intercomparison studies organized by the Community Bureau of Reference on the use of electron spin resonance spectroscopy for the identification of irradiated food are presented. A qualitative intercomparison was carried out using beef and trout bones, sardine scales, pistachio nut shells, dried grapes and papaya. A quantitative intercomparison involving the use of poultry bones was also organized. There was no difficulty in identifying meat bones, dried grapes and papaya. In the case of fish bones there is a need for further kinetic studies using different fish species. The identification of pistachio nut shells is more complicated and further research is needed prior to the organization of a further intercomparison. Laboratories were able to distinguish between chicken bones irradiated in the range 1 to 3 KGy or 7 to 10 KGy although there was a partial overlap between the results from different laboratories

  9. Theoretical study of electron transport throughout some molecular structures

    Science.gov (United States)

    Abbas, Mohammed A. A.; Hanoon, Falah H.; Al-Badry, Lafy F.

    2017-11-01

    The present work is a theoretical study of the electronic properties of some molecular structures. The system that takes into account in the study is left lead-donor-molecule-acceptor-right lead. The molecule, such as (phenyl, biphenyl, triphenyl, naphthalene, anthracene, and phenanthrene), is threaded by magnetic flux. This work contains two parts. First is computing density of states of the molecular structures as a closed system by density functional theory (DFT). Second is calculating the transmission probability and electric current of such molecular structures as an open system by steady-state theoretical model. Furthermore, the most important effects, taking into consideration are quantum interference, magnetic flux, and interface structure. Our results show that the connection of the molecule to the two leads, the number of rings, the magnetic flux, and the geometrical structure of the molecule play an important role in determining the energy gap of molecular structures.

  10. Muon spin relaxation studies in strongly correlated electron systems

    Science.gov (United States)

    Uemura, Y. J.; Luke, G. M.

    1993-05-01

    We describe recent progress of muon spin relaxation (μSR) studies in heavy-fermion (HF) and other strongly correlated electron systems. Measurements of the magnetic field penetration depth λ in HF superconductors UPt 3, URu 2Si 2, UPd 2Al 3 and U 2PtC 2 have revealed that these systems are characterized by large ratios Tc/ TF = 0.1-0.01 of Tc vs Fermi temperature TF derived from λ. This feature is common to high- Tc cuprate and other exotic superconductors. Zero-field μSR studies of magnetic order have elucidated a cross-over from spin glass ordering to nonmagnetic ground states in the ‘quadrupolar Kondo regime’ of (Y 1- xU x)Pd 3, and also suggested a possibility of incommensurate spin-density-wave (SDW) ordering in UNi 2Al 3.

  11. Study of electron beam curing process using epoxy resin system

    Science.gov (United States)

    Nishitsuji, Delmo A.; Marinucci, Gerson; Evora, Maria C.; de Andrade e Silva, Leonardo G.

    2007-12-01

    Polymeric matrix composite (PMC) has been used in engineering applications instead of metal in the last few years, due to its corrosion resistance and excellent relation between tensile strength/density and elastic modulus/density. However, PMC materials cured by thermal process require high temperature and are time-consuming. The electron beam (EB) curing technology allows its use at room temperature and reduced curing times, and this is one of the main advantages over thermal technology. The aim of this work is to investigate electron beam curable epoxy formulations to use in filament winding processes to produce composite material with similar or better properties than thermal curable composites. The study has been made with commercial epoxy resins and cationic initiators. The epoxy resin samples were irradiated for few minutes with total dose of 150 kGy. The glass transition temperatures ( Tg) were determined by dynamic mechanical analyzer (DMA) and the result was 137 °C. The thermal process was carried out in a furnace following three steps: 4 h at 90 °C, increasing temperature from 90 °C to 130 °C during 4 h and 12 h at 130 °C. The total process time was 20 h. The Tg of this sample was 102 °C.

  12. Study of electron beam curing process using epoxy resin system

    Energy Technology Data Exchange (ETDEWEB)

    Nishitsuji, Delmo A. [Centro Tecnologico da Marinha - CTMSP, Sao Paulo/SP (Brazil); Marinucci, Gerson [Instituto de Pesquisas Energeticas e Nucleares, Av. Prof. Lineu Prestes, 2242 Cidade Universitaria, 05508-000 Sao Paulo/SP (Brazil); Evora, Maria C. [Instituto de Estudos Avancados - IEAv/CTA, Sao Jose dos Campos/SP (Brazil); Andrade Silva, Leonardo G de e [Instituto de Pesquisas Energeticas e Nucleares, Av. Prof. Lineu Prestes, 2242 Cidade Universitaria, 05508-000 Sao Paulo/SP (Brazil)], E-mail: lgasilva@ipen.br

    2007-12-15

    Polymeric matrix composite (PMC) has been used in engineering applications instead of metal in the last few years, due to its corrosion resistance and excellent relation between tensile strength/density and elastic modulus/density. However, PMC materials cured by thermal process require high temperature and are time-consuming. The electron beam (EB) curing technology allows its use at room temperature and reduced curing times, and this is one of the main advantages over thermal technology. The aim of this work is to investigate electron beam curable epoxy formulations to use in filament winding processes to produce composite material with similar or better properties than thermal curable composites. The study has been made with commercial epoxy resins and cationic initiators. The epoxy resin samples were irradiated for few minutes with total dose of 150 kGy. The glass transition temperatures (T{sub g}) were determined by dynamic mechanical analyzer (DMA) and the result was 137 deg. C. The thermal process was carried out in a furnace following three steps: 4 h at 90 deg. C, increasing temperature from 90 deg. C to 130 deg. C during 4 h and 12 h at 130 deg. C. The total process time was 20 h. The T{sub g} of this sample was 102 deg. C.

  13. Electronic structure of AlAs: A Compton profile study

    International Nuclear Information System (INIS)

    Sharma, G.; Joshi, K.B.; Mishra, M.C.; Kothari, R.K.; Sharma, Y.C.; Vyas, V.; Sharma, B.K.

    2009-01-01

    The electronic structure of AlAs through a Compton profile study is presented in this paper. Theoretical calculations are performed following the linear combination of atomic orbitals (LCAO) method and the empirical pseudopotential method (EPM). In LCAO method, to treat exchange and correlation two cases are considered. In the first case, the exchange function of Becke and the correlation function of Perdew and Wang on the basis of generalized gradient approximation (PW-GGA) is adopted. In the second case, the hybrid function B3PW is adopted. Measurement of Compton profile on the polycrystalline AlAs is performed using 59.54 keV gamma-rays. The spherically averaged theoretical Compton profiles are in good agreement with the measurement. The best agreement is, however, shown by the EPM. The anisotropies predicted by B3PW and the EPM are smaller than those from the PW-GGA calculation. On the basis of equal-valence-electron-density profiles, it is found that AlAs is more covalent compared to AlN. The charge transfer model suggests transfer of 0.6e - from Al to As on compound formation.

  14. Electronic Structure Studies of Amorphous Hydrogenated Boron Carbide

    Science.gov (United States)

    Sky Driver, M.; Sandstrom, Joseph; Boyko, Teak; Moewes, Alexander; Caruso, Anthony

    2010-03-01

    Boron carbide is a technologically relevant material with importance in voltaic transduction. However, the local physical, chemical and electronic structure of low temperature deposited thin films of amorphous boron carbide is far from understood, hindering its progress in application. X-ray absorption and emission spectroscopies (XAS/XES) were applied to thin films of B4C and B5C:Hx to study the near Fermi edge structure; the films were prepared by RF magnetron sputtering and plasma enhanced chemical vapor deposition (PECVD) and were thermally treated after deposition from 400 to 800 C. XES spectra indicate a physical structure transition from amorphous to nanocrystalline at 700 C, a much lower temperature than expected from traditional physical vapor deposition or flash annealing temperatures reported. These structural differences are of significant interest to transport measurements and will be discussed as a correlation. Further, x-ray and ultraviolet photoemission were also collected as a compliment to XES/XAS and will be discussed in the context of understanding the local intra vs. intermolecular electronic structure of these boron-rich molecular based solids.

  15. Preparation and Comparative Bioavailability Studies of Indomethacin-Loaded Cetyl Alcohol Microspheres

    Directory of Open Access Journals (Sweden)

    N. Vishal Gupta

    2013-01-01

    Full Text Available The purpose of the present study was to compare the in vitro release and to find out whether the bioavailability of a 75 mg indomethacin capsule (Microcid SR was equivalent to optimized formulation (indomethacin-loaded cetyl alcohol microspheres. Indomethacin-loaded cetyl alcohol microspheres were prepared by meltable emulsified cooling-induced technique. Surface morphology of microspheres has been evaluated using scanning electron microscopy. A single dose, randomized, complete cross over study of IM microspheres was carried out on 10 healthy male and female Albino sheep’s under fasting conditions. The plasma was separated and the concentrations of the drug were determined by HPLC-UV method. Plasma indomethacin concentrations and other pharmacokinetic parameters obtained were statistically analyzed. The SEM images revealed the spherical shape of fat microspheres, and more than 98.0% of the isolated microspheres were in the size range 12–32 μm. DSC, FTIR spectroscopy and stability studies indicated that the drug after encapsulation with fat microspheres was stable and compatible. Both formulations were found to be bioequivalent as evidenced by in vivo studies. Based on this study, it can be concluded that cetyl alcohol microspheres and Microcid SR capsule are bioequivalent in terms of the rate and extent of absorption.

  16. Oxidation mechanism of nickel particles studied in an environmental transmission electron microscope

    DEFF Research Database (Denmark)

    Jeangros, Q.; Hansen, Thomas Willum; Wagner, Jakob Birkedal

    2014-01-01

    The oxidation of nickel particles was studied in situ in an environmental transmission electron microscope in 3.2 mbar of O2 between ambient temperature and 600°C. Several different transmission electron microscopy imaging techniques, electron diffraction and electron energy-loss spectroscopy were...

  17. Library usage patterns in the electronic information environment. Electronic journals, Use studies, Libraries, Medical libraries

    Directory of Open Access Journals (Sweden)

    B. Franklin

    2004-01-01

    Full Text Available This paper examines the methodology and results from Web-based surveys of more than 15,000 networked electronic services users in the United States between July 1998 and June 2003 at four academic health sciences libraries and two large main campus libraries serving a variety of disciplines. A statistically valid methodology for administering simultaneous Web-based and print-based surveys using the random moments sampling technique is discussed and implemented. Results from the Web-based surveys showed that at the four academic health sciences libraries, there were approximately four remote networked electronic services users for each in-house user. This ratio was even higher for faculty, staff, and research fellows at the academic health sciences libraries, where more than five remote users for each in-house user were recorded. At the two main libraries, there were approximately 1.3 remote users for each in-house user of electronic information. Sponsored research (grant funded research accounted for approximately 32% of the networked electronic services activity at the health sciences libraries and 16% at the main campus libraries. Sponsored researchers at the health sciences libraries appeared to use networked electronic services most intensively from on-campus, but not from in the library. The purpose of use for networked electronic resources by patrons within the library is different from the purpose of use of those resources by patrons using the resources remotely. The implications of these results on how librarians reach decisions about networked electronic resources and services are discussed.

  18. Pigmentosis tubae, a new entity: light and electron microscopic study

    International Nuclear Information System (INIS)

    Herrera, G.A.; Reimann, B.E.; Greenberg, H.L.; Miles, P.A.

    1983-01-01

    The authors noted an unusual finding in the fallopian tubes of a 31-year-old woman who had received external and internal whole pelvis radiotherapy for squamous cell carcinoma of the cervix. Aggregates of macrophages containing pigment, identified in a subepithelial location, were reminiscent of melanosis coli, which is caused by abuse of anthracene-containing laxatives. Electron microscopic examination of the pigment revealed cytoplasmic material with the appearance of lipofuscin, identical to the pigment described in cases of colonic melanosis. After a careful study of possible etiologic agents, it was concluded that the pigment most likely resulted from cellular damage caused by radiotherapy. The authors are not aware of any other reported case of this entity, which will be called pigmentosis tubae

  19. Electron stimulated desorption study of oxygen adsorption on tungsten

    International Nuclear Information System (INIS)

    Prince, R.H.; Floyd, G.R.

    1978-01-01

    The adsorption of oxygen on a polycrystalline tungsten surface at approximately 800 K has been studied by means of electron stimulated desorption (ESD). Although precision gas dosing was not employed, the initial sticking probability for dissociative adsorption appears to be essentially unity, while the variation with coverage suggests that a high degree of order exists and that precursor state kinetics are significant. A most noticeable and reproducible discontinuity in ESD parameters occurs at a fractional coverage theta approximately 0.8 (exposure approximately 1.4 X 10 15 molecules/cm 2 incident) which is interpreted as an order-disorder transition within a single (β 1 ) chemisorption state, and results in an increase in the ionic desorption cross-section by a factor of approximately 1.26. A discussion of the adsorption kinetics and the disorder transition is given in terms of current models of dissociative adsoption which include the effects of nearest neighbour lateral interactions. (Auth.)

  20. Pulse radiolysis study of one electron oxidation of riboflavin

    International Nuclear Information System (INIS)

    Kishore, K.; Moorthy, P.N.; Guha, S.N.

    1991-01-01

    One electron oxidation of riboflavin (Rf) has been studied using various oxidising species such as Cl 2 -. , SO 4 -. and OH radicals. The transient species produced by the reaction of SO 4 -. with riboflavin gave spectra with λ m at 680 and 640 nm at pHs 4 and 7.1 respectively with a pK a at ∼ 6. Cl 2 -. radicals reacted with riboflavin to give a transient spectrum with λ m at 570 nm. The possibility of two sites viz. C-8 methyl group and the extended π-ring system of the molecule for oxidation reaction are discussed. The reaction of Cl 2 -. with riboflavin is an equilibrium from which the redox potential for the Rf +. /Rf couple has been evaluated to be 2.28 V vs NHE. OH radicals reacted with riboflavin to give a transient spectrum attributable to a mixture of species produced by addition or abstraction reactions. (author)

  1. MUNU: study of the neutrino-electron scattering

    International Nuclear Information System (INIS)

    Cerna, C.

    2000-11-01

    MUNU is an experiment dedicated to electron-neutrino scattering studies and in particular to neutrino magnetic moment search at a nuclear power plant in Bugey (France). MUNU is based on a gaseous time projection chamber (TPC) immersed in 8 tons of liquid scintillator acting as an active anti-Compton shielding. A preliminary analysis of the first results of this experiment corresponding to about 24 days of data collecting draws a line on the value of the neutrino magnetic moment: μ ν -bar e ≤ 1.97 10 -10 μ B (68% confidence level). All along this work, it is shown that the combined use of a TPC and of a light detection system is valuable for discriminating particles and for discarding signals from background noise

  2. Electronic Structure of the Perylene / Zinc Oxide Interface: A Computational Study of Photoinduced Electron Transfer and Impact of Surface Defects

    KAUST Repository

    Li, Jingrui

    2015-07-29

    The electronic properties of dye-sensitized semiconductor surfaces consisting of pery- lene chromophores chemisorbed on zinc oxide via different spacer-anchor groups, have been studied at the density-functional-theory level. The energy distributions of the donor states and the rates of photoinduced electron transfer from dye to surface are predicted. We evaluate in particular the impact of saturated versus unsaturated aliphatic spacer groups inserted between the perylene chromophore and the semiconductor as well as the influence of surface defects on the electron-injection rates.

  3. Experimental studies of stable confined electron clouds using Gabor lenses

    CERN Document Server

    Meusel, O.; Glaeser, B.; Schulte, K.

    2013-04-22

    Based on the idea of D. Gabor [1] space charge lenses are under investigation to be a powerful focussing device for intense ion beams. A stable confined electron column is used to provide strong radially symmetric electrostatic focussing, e.g. for positively charged ion beams. The advantages of Gabor lenses are a mass independent focussing strength, space charge compensation of the ion beam and reduced magnetic or electric fields compared to conventional focussing devices. Collective phenomena of the electron cloud result in aberrations and emittance growth of the ion beam. The knowledge of the behaviour of the electron cloud prevents a decrease of the beam brilliance. Numerical models developed to describe the electron confinement and dynamics within a Gabor lens help to understand the interaction of the ion beam with the electron column and show the causes of non-neutral plasma instabilities. The diagnosis of the electron cloud properties helps to evaluate the numerical models and to investigate the influen...

  4. Experimental study on secondary electron emission characteristics of Cu

    Science.gov (United States)

    Liu, Shenghua; Liu, Yudong; Wang, Pengcheng; Liu, Weibin; Pei, Guoxi; Zeng, Lei; Sun, Xiaoyang

    2018-02-01

    Secondary electron emission (SEE) of a surface is the origin of the multipacting effect which could seriously deteriorate beam quality and even perturb the normal operation of particle accelerators. Experimental measurements on secondary electron yield (SEY) for different materials and coatings have been developed in many accelerator laboratories. In fact, the SEY is just one parameter of secondary electron emission characteristics which include spatial and energy distribution of emitted electrons. A novel experimental apparatus was set up in China Spallation Neutron Source, and an innovative method was applied to obtain the whole characteristics of SEE. Taking Cu as the sample, secondary electron yield, its dependence on beam injection angle, and the spatial and energy distribution of secondary electrons were achieved with this measurement device. The method for spatial distribution measurement was first proposed and verified experimentally. This contribution also tries to give all the experimental results a reasonable theoretical analysis and explanation.

  5. Electron trapping in amorphous silicon: A quantum molecular dynamics study

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Lin H.; Kalia, R.K.; Vashishta, P.

    1990-12-01

    Quantum molecular dynamics (QMD) simulations provide the real-time dynamics of electrons and ions through numerical solutions of the time-dependent Schrodinger and Newton equations, respectively. Using the QMD approach we have investigated the localization behavior of an excess electron in amorphous silicon at finite temperatures. For time scales on the order of a few picoseconds, we find the excess electron is localized inside a void of radius {approximately}3 {Angstrom} at finite temperatures. 12 refs.

  6. BRAND ANALYSIS OF LG ELECTRONICS: A CASE STUDY

    OpenAIRE

    Syed Fida Hussain Shah; Tahira Nazir; Khalid Zaman

    2013-01-01

    LG Electronics is a Korean based global brand in the field of consumer electronics, home appliances and mobile communications. The critical analysis in identifying the steps taken by the LG Electronics in the light of the existing literature review helps us to correlate these steps with the enhanced brand image, brand value and brand positioning. Information is collected from various reports i.e., LG Annual reports; International Magazines from the world of Business and Tech-nology; research ...

  7. Study of electron temperature evolution during sawtoothing and pellet injection using thermal electron cyclotron emission in the Alcator C tokamak

    International Nuclear Information System (INIS)

    Gomez, C.C.

    1986-05-01

    A study of the electron temperature evolution has been performed using thermal electron cyclotron emission. A six channel far infrared polychromator was used to monitor the radiation eminating from six radial locations. The time resolution was <3 μs. Three events were studied, the sawtooth disruption, propagation of the sawtooth generated heatpulse and the electron temperature response to pellet injection. The sawtooth disruption in Alcator takes place in 20 to 50 μs, the energy mixing radius is approx. 8 cm or a/2. It is shown that this is inconsistent with single resonant surface Kadomtsev reconnection. Various forms of scalings for the sawtooth period and amplitude were compared. The electron heatpulse propagation has been used to estimate chi e(the electron thermal diffusivity). The fast temperature relaxation observed during pellet injection has also been studied. Electron temperature profile reconstructions have shown that the profile shape can recover to its pre-injection form in a time scale of 200 μs to 3 ms depending on pellet size

  8. Study of Hydrated Lime in Environmental Scanning Electron Microscopy

    Czech Academy of Sciences Publication Activity Database

    Tihlaříková, Eva; Neděla, Vilém; Rovnaníková, P.

    2013-01-01

    Roč. 19, S2 (2013), s. 1644-1645 ISSN 1431-9276 R&D Projects: GA ČR GAP102/10/1410; GA MŠk ED0017/01/01 Institutional support: RVO:68081731 Keywords : Hydrated Lime * Environmental Scanning Electron Microscopy Subject RIV: JA - Electronics ; Optoelectronics, Electrical Engineering Impact factor: 1.757, year: 2013

  9. AM1 and electron impact mass spectrometry study of the ...

    African Journals Online (AJOL)

    Recently, in electron impact mass spectrometry (EIMS), it has been found a good correlation between the fragmentation processes of coumarins and the electronic charges of the atoms of their skeleton. In this paper, the same analytical method has been applied to 4-acyl isochroman-1,3-diones, whose mass spectra had ...

  10. Theoretical study of near-threshold electron-molecule scattering

    International Nuclear Information System (INIS)

    Morrison, M.A.

    1989-01-01

    We have been engaged in carrying out a foundation study on problems pertaining to near-threshold nuclear excitations in e-H 2 scattering. The primary goals of this study are: to investigate the severity and nature of the anticipated breakdown of the adiabatic-nuclei (AN) approximation, first for rotation only (in the rigid-rotator approximation), and then for vibration; to determine a data base of accurate ab initio cross sections for this important system; to implement and test accurate, computationally-tractable model potentials for exchange and polarization effects; and to begin the exploration of alternative scattering theories for near-threshold collisions. This study has provided a well-defined theoretical context for our future investigations. Second, it has enabled us to identify and quantify several serious problems in the theory of near-threshold electron-molecule scattering that demand attention. And finally, it has led to the development of some of the theoretical and computational apparatus that will form the foundation of future work. In this report, we shall review our progress to date, emphasizing work completed during the current contract year. 17 refs., 5 figs., 1 tab

  11. Ultrastructure of emulsions - a comparative electron microscopy study

    DEFF Research Database (Denmark)

    Jensen, Louise Helene Søgaard

    . For this reason, electron microscopy was the method of choice. However, electron microscopy is inherently performed in vacuum and the emulsions presented a challenge by being liquid systems which are sensitiveto changes in water vapor and temperature. Furthermore, to achieve resolution and contrast of structural...... differences in specimens, electron microscopy relies on the scattering of electrons and the emulsions contain only light elements with low mass contrast. The objective of this thesis was two-fold. One was to identify and further develop sample preparation methods to enable observation of the emulsions...... is added. The Nanomega project, which is a cooperation between the National Food Institute, the Center for Electron Nanoscopy and the Department of Mechanical Engineering, all at the Technical University of Denmark, has dealt mainly with pure oil in water emulsions to describe the oxidation without...

  12. Electronic structure of disordered Au-Pd alloys studied by electron spectroscopies

    Science.gov (United States)

    Nahm, Tschang-Uh; Jung, Ranju; Kim, Jae-Young; Park, W.-G.; Oh, S.-J.; Park, J.-H.; Allen, J. W.; Chung, S.-M.; Lee, Y. S.; Whang, C. N.

    1998-10-01

    The occupied and unoccupied electronic structures of disordered AuxPd1-x alloys are studied by valence-band photoemission, bremsstrahlung isochromat spectroscopy (BIS), and x-ray absorption near-edge spectroscopy (XANES). The occupied partial spectral weights (PSW's) of Au 5d and Pd 4d states are obtained from the valence-band photoemission spectra using synchrotron radiation by taking the matrix-element effect into account. We use the Cooper minimum phenomenon of the Pd 4d states with the measured ratios of photoionization cross sections. The Pd 4d PSW's are found to form a virtual bound state in the Pd-diluted alloy but become broader as the Pd concentration increases due to the Pd 4d-Pd 4d hybridization. On the other hand, Au 5d5/2 states show the common-band behavior due to the appreciable mixing with Pd 4d5/2 states, while Au 5d3/2 states retain their sharp structure and show the split-band behavior. These experimental PSW's of Au-Pd alloys are in good qualitative agreement with the results of recent self-consistent-field coherent-potential-approximation calculations. The comparison of the experimental Pd PSW of Au-Pd with those of other Pd-noble-metal alloys clearly shows that in noble-metal-rich alloys, the mixing of Pd 4d states with host d bands increases in the order of Ag-Pd, Au-Pd, Cu-Pd systems. This trend results in the split-band for Au-Pd and Ag-Pd in Pd diluted alloys, but gives the common band for Cu-Pd. The unoccupied Pd 4d states of disordered AuxPd1-x alloys obtained from BIS and XANES spectra show the gradual filling of Pd 4d states as the Au concentration is increased, but it is not completely filled even in the Pd-diluted alloy.

  13. Electron spin resonance study of radicals in irradiated polyethylene

    International Nuclear Information System (INIS)

    Fujimura, Takashi

    1979-02-01

    In order to elucidate radiation effect in polyethylene, the nature and behavior of radicals produced in polyethylene and the model compound of polyethylene irradiated at 77 0 K were studied by using electron spin resonance. The structure of radical pairs, which are composed of two radicals produced very closely each other, was investigated in drawn polyethylene and the single crystal of n-eicosane. The radical pairs of intrachain type and interchain type were found in polyethylene and n-eicosane respectively. It was suggested that these two types of radical pairs are the precursors of double bonds and crosslinks respectively. The thermal decay reactions of radicals themselves produced in irradiated polyethylene were investigated. It was made clear that the short range distances between two radicals play an important role in the decay reaction of alkyl radicals at low temperatures. The trapping regions of radicals were studied and it was clarified that allyl radicals, which are produced by the reaction of alkyl radicals with double bonds, are trapped both in the crystalline and non-crystalline regions. (author)

  14. Somatic Embryos in Catharanthus roseus: A Scanning Electron Microscopic Study

    Directory of Open Access Journals (Sweden)

    Junaid ASLAM

    2014-06-01

    Full Text Available Catharanthus roseus (L. G. Don is an important medicinal plant as it contains several anti-cancerous compounds, like vinblastine and vincristine. Plant tissue culture technology (organogenesis and embryogenesis has currently been used in fast mass propagating raw materials for secondary metabolite synthesis. In this present communication, scanning electron microscopic (SEM study of somatic embryos was conducted and discussed. The embryogenic callus was first induced from hypocotyls of in vitro germinated seeds on which somatic embryos, differentiated in numbers, particularly on 2,4-D (1.0 mg/L Murashige and Skoog (MS was medium. To understand more about the regeneration method and in vitro formed embryos SEM was performed. The SEM study revealed normal somatic embryo origin and development from globular to heart-, torpedo- and then into cotyledonary-stage of embryos. At early stage, the embryos were clustered together in a callus mass and could not easily be detached from the parental tissue. The embryos were often long cylindrical structure with or without typical notch at the tip. Secondary embryos were also formed on primary embryo structure. The advanced cotyledonary embryos showed prominent roots and shoot axis, which germinated into plantlets. The morphology, structure and other details of somatic embryos at various stages were presented.

  15. Study of Electron Transport and Amplification in Diamond

    Energy Technology Data Exchange (ETDEWEB)

    Ben-Zvi, Ilan [Stony Brook Univ., NY (United States); Muller, Erik [Stony Brook Univ., NY (United States)

    2015-01-05

    The development of the Diamond Amplified Photocathode (DAP) has produced significant results under our previous HEP funded efforts both on the fabrication of working devices and the understanding of the underlying physics governing its performance. The results presented here substantiate the use of diamond as both a secondary electron amplifier for high-brightness, high-average-current electron sources and as a photon and particle detector in harsh radiation environments. Very high average current densities (>10A/cm2) have been transported through diamond material. The transport has been measured as a function of incident photon energy and found to be in good agreement with theoretical models. Measurements of the charge transport for photon energies near the carbon K-edge (290 eV for sp3 bonded carbon) have provided insight into carrier loss due to diffusion; modeling of this aspect of charge transport is underway. The response of diamond to nanosecond x-ray pulses has been measured; in this regime the charge transport is as expected. Electron emission from hydrogenated diamond has been measured using both electron and x-ray generated carriers; a gain of 178 has been observed for electron-generated carriers. The energy spectrum of the emitted electrons has been measured, providing insight into the electron affinity and ultimately the thermal emittance. The origin of charge trapping in diamond has been investigated for both bulk and surface trapping

  16. Theoretical study of ferroelectric nanoparticles using phase reconstructed electron microscopy

    DEFF Research Database (Denmark)

    Phatak, C.; Petford-Long, A. K.; Beleggia, Marco

    2014-01-01

    Ferroelectric nanostructures are important for a variety of applications in electronic and electro-optical devices, including nonvolatile memories and thin-film capacitors. These applications involve stability and switching of polarization using external stimuli, such as electric fields. We present...... a theoretical model describing how the shape of a nanoparticle affects its polarization in the absence of screening charges, and quantify the electron-optical phase shift for detecting ferroelectric signals with phase-sensitive techniques in a transmission electron microscope. We provide an example phase shift...

  17. Study on photoemission mechanism for negative electron affinity GaN vacuum electron source

    International Nuclear Information System (INIS)

    Qiao, Jianliang; Chang, Benkang; Qian, Yunsheng; Wang, Xiaohui; Li, Biao; Fu, Xiaoqian

    2012-01-01

    The whole process including photoelectron excitation, transportation from bulk to surface and escape to vacuum by traversing surface barrier was analyzed in detail. Photoelectron excitation relates to the band structure of photocathode material and the absorption coefficient of the material. In the bulk of GaN photocathode, the photoelectrons mainly are transited into Γ valley first, when the energy is great enough, the photoelectrons can scatter into higher M-L valley or A valley from Γ valley. The electrons excitated in conduction band will move from bulk to surface by diffusing or drifting. The diffuse length for GaN photocathode is about 3μm by calculating. After the thermal electrons of Γ valley move into surface band bend area, they will drift to the surface because of the electric field of band bend area. The transmission coefficient relates to the incident electron energy, the height and width of the surface potential. The quantum yield formulas of NEA GaN photocathode were gotten by solving the diffuse equation of non-equilibrium carriers. (copyright 2012 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim) (orig.)

  18. Study on photoemission mechanism for negative electron affinity GaN vacuum electron source

    Energy Technology Data Exchange (ETDEWEB)

    Qiao, Jianliang [School of Electronic Engineering and Optoelectronic Techniques, Nanjing University of Science and Technology, Nanjing (China); Department of Electronic and Electrical Engineering, Nanyang Institute of Technology, NanYang (China); Chang, Benkang; Qian, Yunsheng; Wang, Xiaohui; Li, Biao; Fu, Xiaoqian [School of Electronic Engineering and Optoelectronic Techniques, Nanjing University of Science and Technology, Nanjing (China)

    2012-01-15

    The whole process including photoelectron excitation, transportation from bulk to surface and escape to vacuum by traversing surface barrier was analyzed in detail. Photoelectron excitation relates to the band structure of photocathode material and the absorption coefficient of the material. In the bulk of GaN photocathode, the photoelectrons mainly are transited into {gamma} valley first, when the energy is great enough, the photoelectrons can scatter into higher M-L valley or A valley from {gamma} valley. The electrons excitated in conduction band will move from bulk to surface by diffusing or drifting. The diffuse length for GaN photocathode is about 3{mu}m by calculating. After the thermal electrons of {gamma} valley move into surface band bend area, they will drift to the surface because of the electric field of band bend area. The transmission coefficient relates to the incident electron energy, the height and width of the surface potential. The quantum yield formulas of NEA GaN photocathode were gotten by solving the diffuse equation of non-equilibrium carriers. (copyright 2012 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim) (orig.)

  19. The Study of Analytical Model of Library Electronic Resources Usage-A Case of Medical Electronic Resources

    Directory of Open Access Journals (Sweden)

    Chung-Yen Yu

    2014-10-01

    Full Text Available With the advents of internet, the importance of electronic resources is growing. Due to the increasing expensiveness of electronic resources, university libraries normally received budgets from parent institutions annually. They necessarily applied effective and systematic methods for decision making in electronic resources purchase or re-subscription. However, there are some difficulties in practices: First of all, libraries are unable to receive user records; second, the COUNTER statistics does not include details about users and their affiliation. As a result, one cannot conduct advanced user analysis based on the usage of users, institutions, and departments. To overcome the difficulties, this study presents a feasible model to analyze electronic resource usage effectively and flexibly. We set up a proxy server to collect actual usage raw data. By analyzing items in internet browsing records, associated with original library automatic system, this study aims at exploring how to use effective ways to analyze big data of website log data. We also propose the process of how original data to be transformed, cleared, integrated, and demonstrated. This study adopted a medical university library and its subscription of medical electronic resources as a case. Our data analysis includes (1 year of subscription,(2 title of journal, (3 affiliation, (4 subjects, and (5 specific journal requirements, etc. The findings of the study are contributed to obtain further understanding in policy making and user behavior analysis. The integrated data provides multiple applications in informatics research, information behavior, bibliomining, presenting diverse views and extended issues for further discussion.

  20. Making of an electronic interferometer to study emissive properties of field-effect microtips. Diffraction and interferences of slow electrons

    International Nuclear Information System (INIS)

    Py, C.

    1993-10-01

    The substitution of hot filaments by field-effect microtips has several advantages in many electronic applications. LETI has already proved the interest of this principle for flat panel displays; many people believe it could also provide novel microwave sources. Moreover, the properties of the emission enable to seek new electron optics applications that were not possible with hot filaments. An interferometry experiment was designed, developed and characterized in order to evaluate the potential of the microtips fabricated in the LETI for such applications. This experiment is composed of a Mollenstedt biprism, of electrostatic lenses and an imaging system composed of deflection plates, a small aperture diaphragm (1 μm) and a channel electron multiplier. Quantum wave effects have been observed, which confirms the good coherence properties of the source. Moreover, this experimental setup enables to better understand the physical phenomenon of the emission of the tips fabricated in the LETI, and to propose some technological improvements for the applications we seek. It is also designed for electron holography applications, and should allow the study of new compact electron optics apparatus taking account of the wave properties of the electrons emitted by microtips. (author). 68 figs. 2 annexes. 41 refs

  1. A study of effective atomic numbers and electron densities of some vitamins for electron, H, He and C ion interactions

    Science.gov (United States)

    Büyükyıldız, M.

    2017-09-01

    The radiological properties of some vitamins such as Retinol, Beta-carotene, Riboflavin, Niacin, Niacinamide, Pantothenic acid, Pyridoxine, Pyridoxamine, Pyridoxal, Biotin, Folic acid, Ascorbic acid, Cholecalciferol, Alpha-tocopherol, Gamma-tocopherol, Phylloquinone have been investigated with respect to total electron interaction and some heavy charged particle interaction as means of effective atomic numbers (Z_{eff}) and electron densities (N_{eff}) for the first time. Calculations were performed for total electron interaction and heavy ions such as H, He and C ion interactions in the energy region 10keV-10MeV by using a logarithmic interpolation method. Variations in Z_{eff}'s and N_{eff}'s of given vitamins have been studied according to the energy of electron or heavy charged particles, and significant variations have been observed for all types of interaction in the given energy region. The maximum values of Z_{eff} have been found in the different energy regions for different interactions remarkably and variations in N_{eff} seem approximately to be the same with variation in Z_{eff} for the given vitamins as expected. Z_{eff} values of some vitamins were plotted together and compared with each other for electron, H, He and C interactions and the ratios of Z_{eff}/ have been changed in the range of 0.25-0.36, 0.20-0.36, 0.22-0.35 and 0.20-0.35 for electron, H, He and C interactions, respectively.

  2. Optimization of power output and study of electron beam energy spread in a Free Electron Laser oscillator

    CERN Document Server

    Abramovich, A; Efimov, S; Gover, A; Pinhasi, Y; Yahalom, A

    2001-01-01

    Design of a multi-stage depressed collector for efficient operation of a Free Electron Laser (FEL) oscillator requires knowledge of the electron beam energy distribution. This knowledge is necessary to determine the voltages of the depressed collector electrodes that optimize the collection efficiency and overall energy conversion efficiency of the FEL. The energy spread in the electron beam is due to interaction in the wiggler region, as electrons enter the interaction region at different phases relative to the EM wave. This interaction can be simulated well by a three-dimensional simulation code such as FEL3D. The main adjustable parameters that determine the electron beam energy spread after interaction are the e-beam current, the initial beam energy, and the quality factor of the resonator out-coupling coefficient. Using FEL3D, we study the influence of these parameters on the available radiation power and on the electron beam energy distribution at the undulator exit. Simulations performed for I=1.5 A, E...

  3. High pressure and synchrotron radiation studies of solid state electronic instabilities

    International Nuclear Information System (INIS)

    Pifer, J.H.; Croft, M.C.

    1992-04-01

    This report discusses Eu and General Valence Instabilities; Ce Problem: L 3 Spectroscopy Emphasis; Bulk Property Emphasis; Transition Metal Compound Electronic Structure; Electronic Structure-Phonon Coupling Studies; High Temperature Superconductivity and Oxide Materials; and Novel Materials Collaboration with Chemistry

  4. The Electron-Phonon Interaction as Studied by Photoelectron Spectroscopy

    International Nuclear Information System (INIS)

    Lynch, D.W.

    2004-01-01

    With recent advances in energy and angle resolution, the effects of electron-phonon interactions are manifest in many valence-band photoelectron spectra (PES) for states near the Fermi level in metals

  5. Electron paramagnetic resonance study of ternary Cu compounds ...

    Indian Academy of Sciences (India)

    , Argentina e-mail: santana@ufg.br. MS received 14 August 2013; revised 31 October 2013; accepted 5 November 2013. Abstract. We report here electron paramagnetic resonance (EPR) measurements at 9 and 34 GHz, and room temperature ...

  6. Cryogenic transmission electron microscopy nanostructural study of shed microparticles.

    Directory of Open Access Journals (Sweden)

    Liron Issman

    Full Text Available Microparticles (MPs are sub-micron membrane vesicles (100-1000 nm shed from normal and pathologic cells due to stimulation or apoptosis. MPs can be found in the peripheral blood circulation of healthy individuals, whereas elevated concentrations are found in pregnancy and in a variety of diseases. Also, MPs participate in physiological processes, e.g., coagulation, inflammation, and angiogenesis. Since their clinical properties are important, we have developed a new methodology based on nano-imaging that provides significant new data on MPs nanostructure, their composition and function. We are among the first to characterize by direct-imaging cryogenic transmitting electron microscopy (cryo-TEM the near-to-native nanostructure of MP systems isolated from different cell types and stimulation procedures. We found that there are no major differences between the MP systems we have studied, as most particles were spherical, with diameters from 200 to 400 nm. However, each MP population is very heterogeneous, showing diverse morphologies. We investigated by cryo-TEM the effects of standard techniques used to isolate and store MPs, and found that either high-g centrifugation of MPs for isolation purposes, or slow freezing to -80 °C for storage introduce morphological artifacts, which can influence MP nanostructure, and thus affect the efficiency of these particles as future diagnostic tools.

  7. Study of electron and neutrino interactions. Final report

    International Nuclear Information System (INIS)

    Abashian, A.

    1997-01-01

    This is the final report for the DOE-sponsored experimental particle physics program at Virginia Tech to study the properties of the Standard Model of strong and electroweak interactions. This contract (DE-AS05-80ER10713) covers the period from August 1, 1980 to January 31, 1993. Task B of this contract, headed by Professor Alexander Abashian, is described in this final report. This program has been pursued on many fronts by the researchers in a search for axions at SLAC, in electron-positron collisions in the AMY experiment at the TRISTAN collider in Japan, in measurements of muon decay properties in the MEGA and RHO experiments at the LAMPF accelerator, in a detailed analysis of scattering effects in the purported observation of a 17 keV neutrino at Oxford, in a search for a disoriented chiral condensate with the MiniMax experiment at Fermilab, and in an R ampersand D program on resistive plate counters that could find use in low-cost high-quality charged particle detection at low rates

  8. Electronic structure of the palladium hydride studied by compton scattering

    CERN Document Server

    Mizusaki, S; Yamaguchi, M; Hiraoka, N; Itou, M; Sakurai, Y

    2003-01-01

    The hydrogen-induced changes in the electronic structure of Pd have been investigated by Compton scattering experiments associated with theoretical calculations. Compton profiles (CPs) of single crystal of Pd and beta phase hydride PdH sub x (x=0.62-0.74) have been measured along the [100], [110] and [111] directions with a momentum resolution of 0.14-0.17 atomic units using 115 keV x-rays. The theoretical Compton profiles have been calculated from the wavefunctions obtained utilizing the full potential linearized augmented plane wave method within the local density approximation for Pd and stoichiometric PdH. The experimental and the theoretical results agreed well with respect to the difference in the CPs between PdH sub x and Pd, and the anisotropy in the CPs of Pd or PdH sub x. This study provides lines of evidence that upon hydride formation the lowest valance band of Pd is largely modified due to hybridization with H 1s-orbitals and the Fermi energy is raised into the sp-band. (author)

  9. Transmission electron microscopy (TEM) study of minerals in coal

    Energy Technology Data Exchange (ETDEWEB)

    Hsieh, Kuang-Chien [Univ. of Illinois, Urbana-Champaign, IL (United States)

    1982-01-01

    Minerals in eight coals from different mines were characterized in the micron-size range by using analytical transmission electron microscopy. Specimens were thinned by ion-milling wafers cut from these coals; a cold stage cooled by liquid nitrogen was used to reduce thermal degradation of the minerals by the ion-beam. Different mineral compounds were observed in different coals. The major minerals are clays, sulfides, oxides, carbonates and some minor-element-bearing phosphates. Clays (kaolinite, illite and others) have been most commonly found as either flat sheets or round globules. Iron sulfide was mostly found in the No. 5 and No. 6 coals from Illinois, distributed as massive polycrystals, as clusters of single crystals (framboids) or as isolated single crystals with size range down to some 0.25 microns. Other sulfides and some oxides were found in other coals with particle size as small as some 200 angstroms. Quartz, titanium oxides and many other carbonates and phosphate compounds were also characterized. Brief TEM work in the organic mass of coal was also introduced to study the nature of the coal macerals.

  10. Electron histochemical and autoradiographic studies of vascular smooth muscle cell

    International Nuclear Information System (INIS)

    Kameyama, Kohji; Aida, Takeo; Asano, Goro

    1982-01-01

    The authors have studied the vascular smooth muscle cell in the aorta and the arteries of brain, heart in autopsied cases, cholesterol fed rabbits and canine through electron histochemical and autoradiographic methods, using 3 H-proline and 3 H-thymidine. The vascular changes are variable presumably due to the functional and morphological difference of vessels. Aging, pathological condition and physiological requirement induce the disturbances of vascular functions as contractility. According to various pathological conditions, the smooth muscle cell altered their shape, surface properties and arrangement of subcellular organelles including changes in number. The morphological features of arteries during aging is characterized by the thickening of endothelium and media. Decreasing cellularity and increasing collagen contents in media. The autoradiographic and histochemical observations using periodic acid methenamine silver (PAM) and ruthenium red stains demonstrated that the smooth muscle cell is a connective tissue synthetic cell. The PAM impregnation have proved that the small bundle of microfilaments become associated with small conglomerate of collagen and elastic fibers. Cytochemical examination will provide sufficient evidence to establish the contribution of subcellular structure. The acid phosphatase play an important role in vascular disease and they are directly involved in cellular lipid metabolism in cholesterol fed animals, and the activity of Na-K ATPase on the plasma membrane may contribute to the regulation of vascular blood flow and vasospasms. Direct injury and subsequent abnormal contraction of smooth muscle cell may initiate increased permeability of plasma protein and lipid in the media layer and eventually may developed and enhance arteriosclerosis. (author)

  11. Scanning and transmission electron microscope study of pellicle morphogenesis.

    Science.gov (United States)

    Lie, T

    1977-05-01

    The morphology of pellicle formation was studied using correlated transmission and scanning electron microscopy. Pellicle developed on hydroxyapatite/epoxy resin splints attached to the buccal surfaces of molars and premolars in six young individuals. Splint segments were removed at intervals of 2, 4, 6, 12, 24, and 48 h. Measurements of pellicle thickness revealed that during the first 12 h considerably more material formed on the apatite surfaces than on the epoxy resin areas of the splints. This difference was equalized in 24- and 48-h specimens. Three types of pellicles could be distinguished on the basis of morphologic criteria. A globular pellicle, characterized by a consistent presence of globules of varying size and configuration, seemed to predominate in most subjects. These globules could not be mistaken for bacteria due to their dimensions, contour, and lack of cell walls. A fibrillar pellicle consisted of 3- to 7-nm-wide fibrils and frequently included some finely globular particles. A granular pellicle displayed a relatively even surface contour and did not exhibit globular or fibrillar structures. In contrast to the two other types, the granular pellicle contained distinct laminations. Apparently, the varying morphology of the early pellicle is a reflection of its complex chemical composition.

  12. Electron holography for the study of nanomagnetic materials

    DEFF Research Database (Denmark)

    Thomas, John Meurig; Simpson, Edward T.; Kasama, Takeshi

    2008-01-01

    holography affords deep insight into magnetic phenomena on the nanoscale. Specifically, we describe the unprecedented level of information available regarding the magnetic nature of magnetotactic bacteria, magnetic nanoparticle chains and chiral bracelets, and geochemically relevant phenomena involving......, our Account concludes with examples of some existing enigmas that electron holography, especially when augmented by the related technique of electron tomography, might play an important experimental role in resolving, such as the occurrence of ferromagnetism in nanocrystals of silver within carbon...

  13. Short-duration Electron Precipitation Studied by Test Particle Simulation

    Directory of Open Access Journals (Sweden)

    Jaejin Lee

    2015-12-01

    Full Text Available Energy spectra of electron microbursts from 170 keV to 340 keV have been measured by the solid-state detectors aboard the low-altitude (680 km polar-orbiting Korean STSAT-1 (Science and Technology SATellite. These measurements have revealed two important characteristics unique to the microbursts: (1 They are produced by a fast-loss cone-filling process in which the interaction time for pitch-angle scattering is less than 50 ms and (2 The e-folding energy of the perpendicular component is larger than that of the parallel component, and the loss cone is not completely filled by electrons. To understand how wave-particle interactions could generate microbursts, we performed a test particle simulation and investigated how the waves scattered electron pitch angles within the timescale required for microburst precipitation. The application of rising-frequency whistler-mode waves to electrons of different energies moving in a dipole magnetic field showed that chorus magnetic wave fields, rather than electric fields, were the main cause of microburst events, which implied that microbursts could be produced by a quasi-adiabatic process. In addition, the simulation results showed that high-energy electrons could resonate with chorus waves at high magnetic latitudes where the loss cone was larger, which might explain the decreased e-folding energy of precipitated microbursts compared to that of trapped electrons.

  14. Electron microscopic study on radiosensitivity of uterine cervical cancer

    International Nuclear Information System (INIS)

    Iwai, Shoji; Shiozawa, Kyuyo; Tsukamoto, Takashi; Noguchi, Hiroshi; Tsukahara, Yoshiharu

    1974-01-01

    The effects of 1000 R of tele-cobalt upon the changes in the primary lesions of uterine cervical cancer with time were studied with an electron microscope. In addition, twenty cases which were proven to have cancer tissues (10 cases of IInd stage of cancer, 8 cases of IIIrd stage of cancer and 2 cases of IVth stage of cancer) were studied. Four cases were favourably sensitive, 7 cases moderately sensitive and 9 cases unfavourably sensitive to radiation. In favourably radio-sensitive cases, the changes in the cancer cells first appeared in the nucleus. There were other changes such as local clumping of chromatin and, specifically, vacuolization of the nucleus. The changes in the endoplasmic reticulum appeared somewhat late. In addition, the disturbance of mitochondria and the decrease or disappearance of ribosomes were specifically due to radiation injury. From the point of view of changes with time, Golgi's apparatus was enlarged and the membrane of the endoplasmic reticulum was degenerated at the 1st day. At the 3rd day, vacuolization of the nucleus appeared, the nuclear corpuscles were increased, the nucleoplasm became thin, and mitochondria was enlarged and degenerated. At the 5th day, the nuclear membrane disappeared, the nucleus was destroyed, large vacuolization of the endoplasmic reticulum was seen, free ribosomes were decreased, and changes around the endoplasmic reticulum were observed. At the 7th day, collagen around the endoplasmic reticulum appeared. In favourably radiosensitive cases, individual tumor cells showed the same degeneration, which fairly corresponded to that evaluated by the histological observation. The disturbance of the cells was caused by radiation, so-called ''burning'' of the cells. Radiation protection of the cells against burning was considered in terms of their radiosensitivity. (K. SERIZAWA)

  15. NMR studies of actinide carbide and nitride electronic properties

    International Nuclear Information System (INIS)

    Boutard, Jean-Louis

    1976-12-01

    N.M.R. studies applied to 13 C and 15 N in the solid solutions ThCsub(1-x)Nsub(x), UCsub(1-x)Nsub(x) and in the compounds ThCsub(1-x) and U 2 C 3 , were undertaken to study carbon and nitrogen contribution to chemical bonds and magnetism. For THORIUM MONOCARBIDE AND CARBONITRIDE: ThCsub(1-x) and ThCsub(1-x)Nsub(x), the very strong orbital contribution to the frequency shift reveals an important covalent character of the valence band 6d metal and 2p metalloid states. The ThCsub(1-x) band structure stoichiometry variation is due to 6dγ metal states appearing at the Fermi level and is in-opposition to a rigid band model. A non-saturated bond mechanism is suggested. For URANIUM CARBONITRIDE: UCsub(1-x)Nsub(x), in the concentration range in which no magnetic order appears at low temperature (x<0.90), the results are in opposition to a localized 5f 2 configuration model, and show that the uranium fundamental state is non-magnetic. Nevertheless two qualitatively different behaviors exist: nitrogen concentration lower than 40%: and nitrogen concentration higher than 40%. A model is proposed to account for those domains: it relies on the 5f-2p hybridization parameter which is maximum on 2p band edge (UC) and almost nul for UN. For URANIUM SESQUICARBIDE: U 2 C 3 : the N.M.R. line observation at 4.2 K indicates a non-magnetic fundamental state although the magnetic susceptibility presents a maximum at 60 K. Spin fluctuations in 5f bands are proposed to describe the electronic properties of this compound. [fr

  16. Miniaturized Environmental Scanning Electron Microscope for In Situ Planetary Studies

    Science.gov (United States)

    Gaskin, Jessica; Abbott, Terry; Medley, Stephanie; Gregory, Don; Thaisen, Kevin; Taylor , Lawrence; Ramsey, Brian; Jerman, Gregory; Sampson, Allen; Harvey, Ralph

    2010-01-01

    The exploration of remote planetary surfaces calls for the advancement of low power, highly-miniaturized instrumentation. Instruments of this nature that are capable of multiple types of analyses will prove to be particularly useful as we prepare for human return to the moon, and as we continue to explore increasingly remote locations in our Solar System. To this end, our group has been developing a miniaturized Environmental-Scanning Electron Microscope (mESEM) capable of remote investigations of mineralogical samples through in-situ topographical and chemical analysis on a fine scale. The functioning of an SEM is well known: an electron beam is focused to nanometer-scale onto a given sample where resulting emissions such as backscattered and secondary electrons, X-rays, and visible light are registered. Raster scanning the primary electron beam across the sample then gives a fine-scale image of the surface topography (texture), crystalline structure and orientation, with accompanying elemental composition. The flexibility in the types of measurements the mESEM is capable of, makes it ideally suited for a variety of applications. The mESEM is appropriate for use on multiple planetary surfaces, and for a variety of mission goals (from science to non-destructive analysis to ISRU). We will identify potential applications and range of potential uses related to planetary exploration. Over the past few of years we have initiated fabrication and testing of a proof-of-concept assembly, consisting of a cold-field-emission electron gun and custom high-voltage power supply, electrostatic electron-beam focusing column, and scanning-imaging electronics plus backscatter detector. Current project status will be discussed. This effort is funded through the NASA Research Opportunities in Space and Earth Sciences - Planetary Instrument Definition and Development Program.

  17. 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

  18. A study of Al/Si interface by photoemission, Auger electron yield and Auger electron spectroscopies

    International Nuclear Information System (INIS)

    Kobayashi, K.L.I.; Barth, J.; Gerken, F.; Kunz, C.; Deutsches Elektronen-Synchrotron

    1980-06-01

    Photoemission, Auger electron yield and Auger electron spectra were observed for Al/Si(111) interfaces with various Al coverage prepared by successive deposition using a molecular beam source. The Al 3p derived states are introduced at around the top of the valence band by the Al coverage of less than one monolayer. The Al surface layer behaves as a 'metal' and the Fermi level is stabilized in the Al 3p derived states at about 0.3 eV above the top of the valence band of Si. The Schottky barrier height in this stage is about 0.8 eV and further increase in Al coverage does not change the barrier height. A covalent bonding model of the Al/Si interface based on the experimental results is proposed. The present result favors the on-top geometry of Al atoms on Si(111) surface among the geometries used in the pseudopotential calculation by Zhang and Schlueter. (orig.)

  19. Study by transmission electron microscopy of ion and electron irradiation defects in zirconium and four alloys

    International Nuclear Information System (INIS)

    Hellio, C.

    1988-01-01

    In order to understand better zirconium growth under irradiation and to estimate the influence of alloying elements, we have performed crystallographic and kinetic analysis of the dislocation loops induced during 500 keV Zr + ion or 1 MeV electron irradiation in pure Zr and four of its alloys: Zr/1760 wt ppm 0. Zr/1 % Nb/430 ppm 0. Zr/1 % Nb/1800 ppm 0 and Zircaloy- 4 . The irradiations were realized between 400 and 700 0 C. The Burgers vectors of the observed loops are a/3 ; the loops lie preferentially on (1010) planes and are aligned along directions parallel to the (0001) plane. The loops induced by 1 MeV electron irradiation and of size larger than 10 nm are of interstitial type. The kinetic analysis shows that oxygen strongly decreases the loop groth speed, the apparent vacancy migration energy increasing from 0.72 eV for pure Zr to 1.76 eV for Zr/1750 ppm 0. The alloying elements (Sn, Nb, 0) increase the loop density. Observation of the microstructural behaviour shows that loops shrink and aggregate during annealing treatments after ion irradiation. This annealing is easier in pure zirconium than in its alloys [fr

  20. Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

    Science.gov (United States)

    2018-02-28

    Hematological Neoplasms; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Lymphoma; Multiple Myeloma; Acute Myeloid Leukemia; Leukemia; Myelodysplastic Syndromes; Neoplasms; Melanoma; Breast Cancer; Metastatic Breast Cancer; Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Renal Cell Carcinoma; Glioblastoma Multiforme; Osteosarcoma; Sarcoma; Thyroid Cancer; Genitourinary

  1. Inter-professional electronic documents and child health: a study of persisting non-electronic communication in the use of electronic documents.

    Science.gov (United States)

    Saario, Sirpa; Hall, Christopher; Peckover, Sue

    2012-12-01

    Information and communication technologies are widely used in health and social care settings to replace previous means of record keeping, assessment and communication. Commentary on the strengths and weaknesses of such systems abound, thus it is useful to examine how they are used in practice. This article draws on findings from two separate studies, conducted between 2005 and 2007, which examined how child health and welfare professionals use electronic documents in Finland and England. Known respectively as Miranda and CAF, these systems are different in terms of structure and function but in their everyday use common features are identified, notably the continued use of and reliance on non-electronic means of communication. Based on interviews with professionals, three forms of non-electronic communication are described: alternative records, phone calls and letters, which facilitate the sharing of the electronic record. Finally, the electronic documents are further analysed as potential boundary objects which aim to create common understanding between sites and professionals. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. Studies of electron cyclotron resonance ion source plasma physics

    International Nuclear Information System (INIS)

    Tarvainen, O.

    2005-01-01

    This thesis consists of an introduction to the plasma physics of electron cyclotron resonance ion sources (ECRIS) and a review of the results obtained by the author and co-workers including discussion of related work by others. The thesis begins with a theoretical discussion dealing with plasma physics relevant for the production of highly charged ions in ECR ion source plasmas. This is followed by an overview of different techniques, such as gas mixing and double frequency heating, that can be used to improve the performance of this type of ion source. The experimental part of the work consists of studies related to ECRIS plasma physics. The effect of the gas mixing technique on the production efficiency of different ion beams was studied with both gaseous and solid materials. It was observed that gas mixing improves the confinement of the heavier element while the confinement of the lighter element is reduced. When the effect of gas mixing on MIVOC-plasmas was studied with several mixing gases it was observed that applying this technique can reduce the inevitable carbon contamination by a significant factor. In order to understand the different plasma processes taking place in ECRIS plasmas, a series of plasma potential and emittance measurements was carried out. An instrument, which can be used to measure the plasma potential in a single measurement without disturbing the plasma, was developed for this work. Studying the plasma potential of ECR ion sources is important not only because it helps to understand different plasma processes, but also because the information can be used as an input parameter for beam transport simulations and ion source extraction design. The experiments performed have revealed clear dependencies of the plasma potential on certain source parameters such as the amount of carbon contamination accumulated on the walls of the plasma chamber during a MIVOC-run. It was also observed that gas mixing affects not only the production efficiency

  3. Study of fast electrons from hard-X radiation; Etude des electrons rapides a partir du rayonnement X-dur

    Energy Technology Data Exchange (ETDEWEB)

    Arslanbekov, R.

    1995-12-19

    The goal of this thesis is the study of fast electron dynamics by means of the hard X-ray diagnosis installed in TORE SUPRA and numerical simulations. Fast electrons are generated in the plasma in the presence of the injected lower hybrid (LH) waves. Two aspects are studied in detail: the lower hybrid wave propagation and absorption in a periodically perturbed media and 2-D Fokker-Planck modelling of the fast electron dynamics in the presence of the LH power. Ripple effects on lower hybrid wave propagation and absorption are investigated using the ray tracing technique. A cylindrical equilibrium is first studied and a strong modification of the ray dynamics is predicted. Calculations are carried out in a real toroidal geometry corresponding to TORE SUPRA. It is shown that the lack of toroidal axisymmetry of the magnetic field may result in a modification of the ray evolution even if the global ray evolution is governed by the larger poloidal inhomogeneity. Simulation of LH experiments are performed for TORE SUPRA tokamak which has a large magnetic ripple (7% at the plasma edge). By considering ripple perturbation in LH current drive simulations, a better agreement is found with experimental results, in particular with the hard-X spectra and the current density profiles. In the second part of the thesis, a 2-D modeling of the fast electron dynamics in the velocity phase space is considered, based on the 2-D relativistic electron Fokker-Planck equation. Electron distribution functions obtained are used to calculate non-thermal Bremsstrahlung emission for different TORE SUPRA shots in a wide range of experimental conditions. (J.S.). 168 refs., 93 figs., 1 tab., 3 appendix.

  4. Electronic Structures of Silicene Doped with Galium: First Principle study

    Directory of Open Access Journals (Sweden)

    Pamungkas Mauludi Ariesto

    2015-01-01

    Full Text Available Following the success of graphene which possesses unique and superior properties, 2D material other than graphene become centre of interest of material scientists.Silicene, which has the same crystal structure as graphene but consist of silicon atoms rather than carbon become intriguing material due to domination of silicon as main material of electronic component. It is common to enhance electronic properties of semiconductor by adding dopant atoms. The electronic properties of Silicene doped with Gallium are investigated using first principle calculation based on density functional theory (DFT.Ga doping changes character of silicene from semimetal to conductor except silicene with Ga doping on S-site (Ga atom substitutes one Si atom which lead to semiconductor.

  5. Studies on electronic structure of GaN(0001) surface

    CERN Document Server

    Xie Chang Kun; Xu Fa Qiang; Deng Rui; Liu Feng; Yibulaxin, K

    2002-01-01

    An electronic structure investigation on GaN(0001) is reported. The authors employ a full-potential linearized augmented plane-wave (FPLAPW) approach to calculate the partial density of state, which is in agreement with previous experimental results. The effects of the Ga3d semi-core levels on the electronic structure of GaN are discussed. The valence-electronic structure of the wurtzite GaN(0001) surface is investigated using synchrotron radiation excited angle-resolved photoemission spectroscopy. The bulk bands dispersion along GAMMA A direction in the Brillouin zones is measured using normal-emission spectra by changing photon-energy. The band structure derived from authors' experimental data is compared well with the results of authors' FPLAPW calculation. Furthermore, off-normal emission spectra are also measured along the GAMMA K and GAMMA M directions. Two surface states are identified, and their dispersions are characterized

  6. BRAND ANALYSIS OF LG ELECTRONICS: A CASE STUDY

    Directory of Open Access Journals (Sweden)

    Syed Fida Hussain Shah

    2013-04-01

    Full Text Available LG Electronics is a Korean based global brand in the field of consumer electronics, home appliances and mobile communications. The critical analysis in identifying the steps taken by the LG Electronics in the light of the existing literature review helps us to correlate these steps with the enhanced brand image, brand value and brand positioning. Information is collected from various reports i.e., LG Annual reports; International Magazines from the world of Business and Tech-nology; research literatures and other reputable sources. Innovation & design and constant obsolescence of ICT and IT Products (i.e., mobiles in particular, LG have to stick on R&D, design strategies and innovation and creativity for competing in the global market.

  7. Comparative study of electron microscopy and scanning probe microscopy in photosynthetic research

    OpenAIRE

    MATĚNOVÁ, Martina

    2009-01-01

    The aim of this study is to compare the ability of transmission electron microscopy, scanning electron microscopy and atomic force microscopy to visualize individual protein complexes. The principle of electron microscopy and atomic force microscopy is explained. For comparision of these methods well characterized photosynthetic complexes LH1, LH2, PSI and PSII were selected.

  8. 78 FR 5816 - Electronic Study Data Submission; Data Standard Support End Date

    Science.gov (United States)

    2013-01-28

    ...] Electronic Study Data Submission; Data Standard Support End Date AGENCY: Food and Drug Administration, HHS... Safety and Innovation Act (FDASIA) (Public Law 112- 144), requires electronic submission of drug and... comment, will specify the format required for such electronic submissions. The action announced in this...

  9. Studies of electron drift velocity in nitrogen and isobutane

    Energy Technology Data Exchange (ETDEWEB)

    Goncalves, Josemary A.C.; Botelho, Suzana; Tobias, Carmen C.B. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil); Pontificia Univ. Catolica de Sao Paulo (PUC/SP), SP (Brazil); Vivaldini, Tulio C.; Lima, Iara B. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil); Ridenti, Marco A.; Pascholati, Paulo R. [Universidade de Sao Paulo (USP), SP (Brazil). Inst. de Fisica. Lab. do Acelerador Linear; Fonte, Paulo; Mangiarotti, Alessio [Universidade de Coimbra (Portugal). Dept. de fisica. Lab. de Instrumentacao e Fisica Experimental de Particulas

    2009-07-01

    Full text: The electron drift velocity is one of the most important transport parameters used to describe the physical behaviour of gas discharges and the development of avalanches in gaseous detectors, mainly when temporal information is significant, as in drift chambers and in the recent Resistive Plate Chambers (RPCs). Although many filling gases, isobutane is frequently used in RPCs, due to its excellent timing properties, but at high electric fields conditions there are insufficient data available in literature. In the present work we report the preliminary results related to the dependence of the electron drift velocity for isobutane as function of the reduced electric field E/N, in the range of 100 Td up to 216 Td. There are different methods to determine electron drift velocity in a gas, and our measurements were based on the Pulsed Townsend technique, which consists of extracting electrons from a metallic cathode and accelerates them toward the anode by a uniform electric field. Once the drift distance and the transit time are known, the drift velocities can be determined. In our system, the incidence of a nitrogen laser beam (LTB MNL200-LD) liberates electron from the cathode made of aluminium (40mm diameter). By means of a high voltage supply (Bertan, 225-30), these electrons are accelerated toward the anode (made of a high resistivity glass - 2:10{sup 12}{omega} cm) and this movement produces a fast electric signal in the anode, which is digitalized in an oscilloscope (LeCroy WavePro 7000) with 1 GHz bandwidth and 10 GS/s. The values obtained were compared to that ones of a Bolsig+ simulation code. In order to validate the technique and to analyze non-uniformity effects, results for nitrogen are also presented. (author)

  10. Studies of electron drift velocity in nitrogen and isobutane

    International Nuclear Information System (INIS)

    Goncalves, Josemary A.C.; Botelho, Suzana; Tobias, Carmen C.B.; Vivaldini, Tulio C.; Lima, Iara B.; Ridenti, Marco A.; Pascholati, Paulo R.; Fonte, Paulo; Mangiarotti, Alessio

    2009-01-01

    Full text: The electron drift velocity is one of the most important transport parameters used to describe the physical behaviour of gas discharges and the development of avalanches in gaseous detectors, mainly when temporal information is significant, as in drift chambers and in the recent Resistive Plate Chambers (RPCs). Although many filling gases, isobutane is frequently used in RPCs, due to its excellent timing properties, but at high electric fields conditions there are insufficient data available in literature. In the present work we report the preliminary results related to the dependence of the electron drift velocity for isobutane as function of the reduced electric field E/N, in the range of 100 Td up to 216 Td. There are different methods to determine electron drift velocity in a gas, and our measurements were based on the Pulsed Townsend technique, which consists of extracting electrons from a metallic cathode and accelerates them toward the anode by a uniform electric field. Once the drift distance and the transit time are known, the drift velocities can be determined. In our system, the incidence of a nitrogen laser beam (LTB MNL200-LD) liberates electron from the cathode made of aluminium (40mm diameter). By means of a high voltage supply (Bertan, 225-30), these electrons are accelerated toward the anode (made of a high resistivity glass - 2:10 12 Ω cm) and this movement produces a fast electric signal in the anode, which is digitalized in an oscilloscope (LeCroy WavePro 7000) with 1 GHz bandwidth and 10 GS/s. The values obtained were compared to that ones of a Bolsig+ simulation code. In order to validate the technique and to analyze non-uniformity effects, results for nitrogen are also presented. (author)

  11. Electronic systems study topics in physics book 8

    CERN Document Server

    Bolton, William

    2013-01-01

    Electronic Systems is concerned with electronic systems such as sine-wave oscillators, amplifiers with negative feedback, operational amplifiers, analogue and digital computers, switching circuits, bistable circuits, and microprocessors. This text is comprised of five chapters; the first of which introduces the basic ideas of a system, feedback, control, and logic gates. Examples of feedback and closed-loop control are given, and the distinction between the effects of positive and negative feedback is described, along with the functions of AND, OR, NOT, NOR, and NAND logic gates. The next chap

  12. Study of hot electrons in a ECR ion source

    International Nuclear Information System (INIS)

    Barue, C.

    1992-12-01

    The perfecting of diagnosis connected with hot electrons of plasma, and then the behaviour of measured parameters of plasma according to parameters of source working are the purpose of this thesis. The experimental results obtained give new information on hot electrons of an ECR ion source. This thesis is divided in 4 parts: the first part presents an ECR source and the experimental configuration (ECRIS physics, minimafios GHz, diagnosis used); the second part, the diagnosis (computer code of cyclotron emission and calibration); the third part gives experimental results in continuous regime (emission cyclotron diagnosis, bremsstrahlung); the fourth part, experimental results in pulsed regime (emission cyclotron diagnosis, diamagnetism) calibration)

  13. Monte Carlo studies of thermalization of electron-hole pairs in spin-polarized degenerate electron gas in monolayer graphene

    Science.gov (United States)

    Borowik, Piotr; Thobel, Jean-Luc; Adamowicz, Leszek

    2018-02-01

    Monte Carlo method is applied to the study of relaxation of excited electron-hole (e-h) pairs in graphene. The presence of background of spin-polarized electrons, with high density imposing degeneracy conditions, is assumed. To such system, a number of e-h pairs with spin polarization parallel or antiparallel to the background is injected. Two stages of relaxation: thermalization and cooling are clearly distinguished when average particles energy and its standard deviation σ _E are examined. At the very beginning of thermalization phase, holes loose energy to electrons, and after this process is substantially completed, particle distributions reorganize to take a Fermi-Dirac shape. To describe the evolution of and σ _E during thermalization, we define characteristic times τ _ {th} and values at the end of thermalization E_ {th} and σ _ {th}. The dependence of these parameters on various conditions, such as temperature and background density, is presented. It is shown that among the considered parameters, only the standard deviation of electrons energy allows to distinguish between different cases of relative spin polarizations of background and excited electrons.

  14. First combined electron backscatter diffraction and transmission electron microscopy study of grain boundary structure of deformed quartzite.

    Science.gov (United States)

    Shigematsu, N; Prior, D J; Wheeler, J

    2006-12-01

    The structures of boundaries in a deformed and dynamically recovered and recrystallized quartz polycrystal (mylonite) were characterized by transmission electron microscopy, after the misorientation angles across the same grain boundaries had been analysed using electron backscatter diffraction in a scanning electron microscope. In this new approach, a specific sample area is mapped with electron backscatter diffraction, and the mapped area is then attached to a foil, and by the ion beam thinned for transmission electron microscopy analysis. Dislocations in grain boundaries were recognized as periodic and parallel fringes. The fringes associated with dislocations are observed in boundaries with misorientations less than 9 degrees , whereas such fringes cannot be seen in the boundaries with misorientations larger than 17 degrees . Some boundaries with misorientations between 9 degrees and 17 degrees generally have no structures associated with dislocation. One segment of a boundary with a misorientation of 13.5 degrees has structures associated with dislocations. It is likely that the transition from low-angle to high-angle boundaries occurs at misorientations ranging from approximately 9 degrees to 14 degrees . Change in the grain boundary structure presumably influences the mobility of the boundaries. In the studied deformed quartz vein, a relative dearth of boundaries between misorientation angles of theta = 2 degrees and theta = 15 degrees has previously been reported, and high-angle boundaries form cusps where they intersect low-angle boundaries, suggesting substantial mobility of high-angle boundaries.

  15. Empirical pseudo-potential studies on electronic structure of ...

    Indian Academy of Sciences (India)

    Wintec

    Abstract. Theoretical investigations of electronic structure of quantum dots is of current interest in nano- phase materials. Empirical theories such as effective mass approximation, tight binding methods and empirical pseudo-potential method are capable of explaining the experimentally observed optical properties.

  16. Density functional theory study of structure, electronic and magnetic ...

    Indian Academy of Sciences (India)

    Keywords. Rhodium; boron; aluminium; gallium; methanol activation. Abstract. Rhodium clusters are very important finite size materials because of their unique electronic, magneticand catalytic properties. Tuning the physical and chemical properties of rhodium clusters by incorporatingdifferent metal and non-metal atoms ...

  17. Study of runaway electron generation during major disruptions in JET

    Czech Academy of Sciences Publication Activity Database

    Plyusnin, V.V.; Riccardo, V.; Jaspers, R.; Alper, B.; Kiptily, V.G.; Mlynář, Jan; Popovichev, S.; de La Luna, E.; Andersson, F.

    2006-01-01

    Roč. 46, č. 2 (2006), s. 277-284 ISSN 0029-5515 Institutional research plan: CEZ:AV0Z2043910 Keywords : JET * tokamak * fusion * dicsruption * runaway electrons * tomography Subject RIV: BL - Plasma and Gas Discharge Physics Impact factor: 2.839, year: 2006

  18. A comparative study between all-electron scalar relativistic ...

    Indian Academy of Sciences (India)

    gold cluster and the reactivity enhancement of H2 molecule. It may be one of the reasons why the dissociative .... computational method and cluster model are described in section 2, calculation results and discussions are ... core electrons; instead they supplement the core poten- tials with approximate relativistic effects.

  19. Studying privacy in electronic voting protocols and comparing its ...

    African Journals Online (AJOL)

    Then results of the investigations were given and the methods of providing privacy in the protocols were introduced. In the end these methods were examined and compared and the homomorphic encryption was proposed as the best method. Keywords: electronic voting; privacy; homomorphic encryption; blind signature ...

  20. Density functional study of : Electronic and optical properties

    Indian Academy of Sciences (India)

    K C Bhamu

    2017-06-20

    Jun 20, 2017 ... used as an inner layer of solar cells for electricity gen- eration. This peculiar characteristic has established a benchmark in invisible electronics and opened a new era in solar cell technology [5–9]. Dietrich and Jansen [10] synthesized and reported the 3R phase of AgScO2. Shannon et al [11] reported.

  1. Empirical pseudo-potential studies on electronic structure

    Indian Academy of Sciences (India)

    Theoretical investigations of electronic structure of quantum dots is of current interest in nanophase materials. Empirical theories such as effective mass approximation, tight binding methods and empirical pseudo-potential method are capable of explaining the experimentally observed optical properties. We employ the ...

  2. Studies on electron transfer reactions: Reduction of heteropoly 10 ...

    Indian Academy of Sciences (India)

    Rates of electron transfer reaction of thioglycolic acid with vanadium(V) substituted Keggintype heteropolyanion, [PVVVVW10O40]5-, in acetate-acetic acid buffers have been measured spectrophotometrically at 25°C. The order of the reaction with respect to substrate and oxidant is unity. The reaction shows simple second ...

  3. Density functional theory study of structure, electronic and magnetic ...

    Indian Academy of Sciences (India)

    ABHIJIT DUTTA

    2018-01-30

    Jan 30, 2018 ... Abstract. Rhodium clusters are very important finite size materials because of their unique electronic, magnetic and catalytic properties. Tuning the physical and chemical properties of rhodium clusters by incorporating different metal and non-metal atoms have found a great research interest in recent years.

  4. Comparative study of electron conduction in azulene and naphthalene

    Indian Academy of Sciences (India)

    Wintec

    in our systems as a response of the external electric field. Parallely we have performed the Gaussian calcula- tions with electric field in the same bias window to observe the impact of external bias on the wave functions of the systems. ..... ring, whereas reverse bias drives the electrons opposite to the dipole moment direc-.

  5. Studying the electronic customer relationship management and its ...

    African Journals Online (AJOL)

    ... was returned after distributing of 80 samples. Hypotheses of research have been analyzed using spss software and Spearman correlation test. The results prove all hypotheses of research. Keywords: Electronic Banking, Service Quality, Customer Satisfaction, Management of. Relationship with Customer, Commitment ...

  6. Fuse Modeling for Reliability Study of Power Electronic Circuits

    DEFF Research Database (Denmark)

    Bahman, Amir Sajjad; Iannuzzo, Francesco; Blaabjerg, Frede

    2017-01-01

    This paper describes a comprehensive modeling approach on reliability of fuses used in power electronic circuits. When fuses are subjected to current pulses, cyclic temperature stress is introduced to the fuse element and will wear out the component. Furthermore, the fuse may be used in a large v...

  7. Studies on electron transfer reactions: Reduction of heteropoly 10 ...

    Indian Academy of Sciences (India)

    Administrator

    Abstract. Rates of electron transfer reaction of thioglycolic acid with vanadium(V) substituted Keggin- type heteropolyanion, [PV ... By applying Rehm–Weller relationship, self exchange rate constant for the. –. SCH2COO. –. /S. •. CH2COO. – .... is much more higher than that of mono-anion. HSCH2COO–. 3.4 Marcus theory.

  8. Electronic and optical properties of spodumene gemstone: A theoretical study

    Science.gov (United States)

    de Lima, A. F.; Souza, S. O.; Lalic, M. V.

    2008-03-01

    The spodumene (LiAlSi 2O 6) is a natural silicate with monoclinic structure, interesting for a jewel industry and possible application as a scintillator. In this paper we present the electronic structure and some of the basic optical properties of the pure spodumene crystal, as calculated by the first-principles, density functional based, full potential linear augmented plane wave method.

  9. A study of electron scattering through noise spectroscopy

    NARCIS (Netherlands)

    Kumar, Manohar

    2012-01-01

    Charge counting statistics (C.S.) of traversing electron in quantum devices like atomic-molecular junctions is sensitive to the local perturbation in the charge field at the contact and in the quantum channels. The first cumulant of C.S. i.e. current-voltage characteristic of such devices has been

  10. Application of maximum entropy method for the study of electron ...

    Indian Academy of Sciences (India)

    demonstrate that the integrated powder data can be used for the analysis of electron density distribution using MEM and the bonding features can be understood in a better manner. However, the limitations lie in the quality of powder data sets used for the analysis. 2. Data treatment. The powder data of SrS, BaS and PuS ...

  11. Human enamel structure studied by high resolution electron microscopy

    International Nuclear Information System (INIS)

    Wen, S.L.

    1989-01-01

    Human enamel structural features are characterized by high resolution electron microscopy. The human enamel consists of polycrystals with a structure similar to Ca10(PO4)6(OH)2. This article describes the structural features of human enamel crystal at atomic and nanometer level. Besides the structural description, a great number of high resolution images are included. Research into the carious process in human enamel is very important for human beings. This article firstly describes the initiation of caries in enamel crystal at atomic and unit-cell level and secondly describes the further steps of caries with structural and chemical demineralization. The demineralization in fact, is the origin of caries in human enamel. The remineralization of carious areas in human enamel has drawn more and more attention as its potential application is realized. This process has been revealed by high resolution electron microscopy in detail in this article. On the other hand, the radiation effects on the structure of human enamel are also characterized by high resolution electron microscopy. In order to reveal this phenomenon clearly, a great number of electron micrographs have been shown, and a physical mechanism is proposed. 26 references

  12. Electron microscopical studies of the common bile duct in reindeer

    Directory of Open Access Journals (Sweden)

    Timo Rahko

    1990-08-01

    Full Text Available In a previous publication the authors have described some ultrastructural characteristics of granulated cells in the common bile duct of the reindeer. On the basis of the same material, electron microscopic observations on other tissue elements of bile duct wall are now reported. The surface and glandular epithelium were composed of tall columnar epithelial cells with villous structures on the luminal surfaces. The parietal cytoplasmic membranes of epithelial cells were equipped with intercellular desmosomes while intraepithelial globule leucocytes did not form any junctional complex with other cells. Apical cytoplasmic areas of superficial epithelial cells showed electron-dense small bodies possibly consisting of mucinous substances. The goblet and deep glandular cells, on the other hand, contained numerous large mucin granules with less electron-dense matrices. It appears that their secretions are more abundant than those in superficial epithelial cells which obviously are absorptive as their main function. The nuclei and other cytoplasmic organelles showed profiles similar to those in epithelial cells generally. The lumen of the bile ducts was usually empty or contained fine-granular or amorphous material. An unusual feature was the presence of parts of globule leucocytes or even almost whole cells occurring freely in ductal secretions.Elektronimikroskooppinen tutkimus yhteisen sappikäytävän rakenteesta porolla.Abstract in Finnish / Yhteenveto: Aikaisemmassa julkaisussa tekijät kuvasivat poron yhteisen sappikäytävän (ductus hepaticus communis seinämän jyväsellisten solujen hienorakennetta. Tässä artikkelissa selostetaan saman aineiston perusteella (6 tervettä teurasporoa elektronimikroskooppisia havaintoja sappikäytäväseinämän muista kudosrakenteista. Sappikäytäväseinämän pinta- ja rauhasepiteeli koostuu korkeista epiteelisoluista. Pinnallisia epiteelisoluja kattavat säännölliset mikrovillukset, ja niillä on vain v

  13. Electron microscopy study of antioxidant interaction with bacterial cells

    Science.gov (United States)

    Plotnikov, Oleg P.; Novikova, Olga V.; Konnov, Nikolai P.; Korsukov, Vladimir N.; Gunkin, Ivan F.; Volkov, Uryi P.

    2000-10-01

    To maintain native microorganisms genotype and phenotype features a lyophylization technique is widely used. However in this case cells are affected by influences of vacuum and low temperature that cause a part of the cells population to be destruction. Another factor reduced microorganisms vitality is formation of reactive oxygen forms that damage certain biological targets (such as DNA, membranes etc.) Recently to raise microorganism's resistance against adverse condition natural and synthetic antioxidants are used. Antioxidant- are antagonists of free radicals. Introduction of antioxidants in protective medium for lyophylization increase bacteria storage life about 2,0-4,8 fold in comparison with reference samples. In the article the main results of our investigation of antioxidants interaction with microorganism cells is described. As bacteria cells we use vaccine strain yersinia pestis EV, that were grown for 48 h at 28 degree(s)C on the Hottinger agar (pH 7,2). Antioxidants are inserted on the agar surface in specimen under test. To investigate a localization of antioxidants for electron microscopy investigation, thallium organic antioxidants were used. The thallium organic compounds have an antioxidant features if thallium is in low concentration (about 1(mu) g/ml). The localization of the thallium organic antioxidants on bacteria Y. pestis EV is visible in electron microscopy images, thallium being heavy metal with high electron density. The negatively stained bacteria and bacteria thin sections with thallium organic compounds were investigated by means of transmission electron microscopy. The localization of the thallium organic compounds is clearly visible in electron micrographs as small dark spots with size about 10-80nm. Probably mechanisms of interaction of antioxidants with bacteria cells are discussed.

  14. Electronic Health in Perspective of Healthcare Managers: A Qualitative Study in South of Iran.

    Science.gov (United States)

    Bastani, Peivand; Abolhasani, Nazanin; Shaarbafchizadeh, Nasrin

    2014-06-01

    The important role of electronic health as well as importance of health care systems awareness and readiness may lead to develop the essential infrastructures for electronic health especially in developing countries. This study aims to investigate goals, gains, applications, challenges and other important issues related to success performance of electronic health. This research proposed a grounded theory in a qualitative design and a purposive sampling was used to select participants which consisted of 28 hospital managers and staff field managers working in deputy of health and curative affairs of Medical Science Universities in south of Iran. Semi structured interviews were conducted using a topic guide and intended themes derived from the results using Max QDA software during five steps. Nine themes through interviewees" viewpoints were made up as followed: Electronic health definition, necessity and importance of electronic health, electronic health advantages, relationship between electronic health and internet, physicians" opposition to electronic health, prerequisites for electronic health, solutions for applying electronic health plan, factors affecting electronic health acceptance in society and electronic health system challenges. It seems that there are good circumstances in the south medical universities about settlement and implementations of electronic health and their managers are aware of its advantages, importance and necessities. The present findings implicate that these organizations should consider the user friendly and probable resistances of the present clients, in this regard it is suggested that the used technology must be accepted by users, having standard base, inexpensive and simple enough while less vulnerable in response to changes.

  15. Electronic properties and Compton scattering studies of monoclinic tungsten dioxide

    Science.gov (United States)

    Heda, N. L.; Ahuja, Ushma

    2015-01-01

    We present the first ever Compton profile measurement of WO2 using a 20 Ci 137Cs γ-ray source. The experimental data have been used to test different approximations of density functional theory in linear combination of atomic orbitals (LCAO) scheme. It is found that theoretical Compton profile deduced using generalized gradient approximation (GGA) gives a better agreement than local density approximation and second order GGA. The computed energy bands, density of states and Mulliken's populations (MP) data confirm a metal-like behavior of WO2. The electronic properties calculated using LCAO approach are also compared with those obtained using full potential linearized augmented plane wave method. The nature of bonding in WO2 is also compared with isoelectronic WX2 (X=S, Se) compounds in terms of equal-valence-electron-density profiles and MP data, which suggest an increase in ionic character in the order WSe2→WS2→WO2.

  16. Electronics: Mott Transistor: Fundamental Studies and Device Operation Mechanisms

    Science.gov (United States)

    2016-03-21

    semiconductors and their response to electric fields. This is relevant to their eventual use as advanced semiconductors in microwave devices or high speed...ADDRESS (ES) U.S. Army Research Office P.O. Box 12211 Research Triangle Park, NC 27709-2211 oxide, electronics, semiconductors , correlated REPORT...project include advancing our understanding of strong correlation effects in Mott semiconductors and their response to electric fields. This is relevant

  17. Electron microscopy study of the iron meteorite Santa Catharina

    Science.gov (United States)

    Zhang, J.; Williams, D. B.; Goldstein, J. I.; Clarke, R. S., Jr.

    1990-01-01

    A characterization of the microstructural features of Santa Catharina (SC) from the millimeter to submicron scale is presented. The same specimen was examined using an optical microscope, a scanning electron microscope, an electron probe microanalyzer, and an analytical electron microscope. Findings include the fact that SC metal nodules may have different bulk Ni values, leading to different microstructures upon cooling; that SC USNM 6293 is the less corroded sample, as tetrataenite exists as less than 10 nm ordered domains throughout the entire fcc matrix (it is noted that this structure is the same as that of the Twin City meteorite and identical to clear taenite II in the retained taenite regions of the octahedrites); that SC USNM 3043 has a more complicated microstructure due to corrosion; and that the low Ni phase of the cloudy zone was selectively corroded in some areas and formed the dark regions, indicating that the SC meteorite corrosion process was electrochemical in nature and may involve Cl-containing akaganeite.

  18. First Principles Study of Electron Tunneling through Ice

    KAUST Repository

    Cucinotta, Clotilde S.

    2012-10-25

    With the aim of understanding electrochemical scanning tunnel microscopy experiments in an aqueous environment, we investigate electron transport through ice in the coherent limit. This is done by using the nonequilibrium Greens functions method, implemented within density functional theory, in the self-interaction corrected local density approximation. In particular, we explore different ice structures and different Au electrode surface orientations. By comparing the decay coefficient for different thicknesses to the ice complex band structure, we find that the electron transport occurs via tunneling with almost one-dimensional character. The slow decay of the current with the ice thickness is largely due to the small effective mass of the conduction electrons. Furthermore, we find that the calculated tunneling decay coefficients at the Fermi energy are not sensitive to the structural details of the junctions and are at the upper end of the experimental range for liquid water. This suggests that linear response transport measurements are not capable of distinguishing between different ordered ice structures. However, we also demonstrate that a finite bias measurement may be capable of sorting polar from nonpolar interfaces due to the asymmetry of the current-voltage curves for polar interfaces. © 2012 American Chemical Society.

  19. TECHNIQUES FOR THE STUDY OF THE ELECTRONIC PROPERTIES.

    Energy Technology Data Exchange (ETDEWEB)

    FERNANDEZ-GARCIA, M.; RODRIGUEZ, J.A.

    2006-06-30

    The electronic structure of a solid is affected by size and altered from the continuous electronic levels forming a band, characteristic of bulk or microsized solids, to discrete-like or quantized levels. This is drastically observed when the particle size goes down to the nano-meter range and is the origin of the so-called ''quantum confinement'' terminology referring to this phenomenon. From a solid state point of view, electronic states of confined materials can be considered as being a superposition of bulk-like states with a concomitant increase of the oscillator strength. The valence/conduction band-width and position observables of a solid oxide are functions of the crystal potential and this, in turn, is perturbed by effect of the size in two ways; a short-range effect induced by the presence of ions with a different coordination number and bond distance, and a large-range one, induced by changes in the Madelung potential of the oxide. Theoretical analyses for oxides show a redistribution of charge when going from large periodic structures to small clusters which is roughly considered small for ionic solids and significantly important for covalent ones. Chapter 1 of this book describes the most recent theoretical frameworks employed to deal with these physical phenomena while here we will describe their influence in physico-chemical observables obtained by spectroscopical techniques.

  20. First electron-cloud studies at the Large Hadron Collider

    Science.gov (United States)

    Domínguez, O.; Li, K.; Arduini, G.; Métral, E.; Rumolo, G.; Zimmermann, F.; Cuna, H. Maury

    2013-01-01

    During the beam commissioning of the Large Hadron Collider (LHC) [LHC Design Report No. CERN-2004-003-V-1, 2004 [http://cds.cern.ch/record/782076?ln=en]; O. Brüning, H. Burkhardt, and S. Myers, Prog. Part. Nucl. Phys. 67, 705 (2012)10.1016/j.ppnp.2012.03.001PPNPDB0146-6410] with 150, 75, 50, and 25-ns bunch spacing, important electron-cloud effects, like pressure rise, cryogenic heat load, beam instabilities, or emittance growth, were observed. Methods have been developed to infer different key beam-pipe surface parameters by benchmarking simulations and pressure rise as well as heat-load observations. These methods allow us to monitor the scrubbing process, i.e., the reduction of the secondary emission yield as a function of time, in order to decide on the most appropriate strategies for machine operation. To better understand the influence of electron clouds on the beam dynamics, simulations have been carried out to examine both the coherent and the incoherent effects on the beam. In this paper we present the methodology and first results for the scrubbing monitoring process at the LHC. We also review simulated instability thresholds and tune footprints for beams of different emittance, interacting with an electron cloud in field-free or dipole regions.

  1. Electron cloud studies for the LHC and future proton colliders

    CERN Document Server

    Domínguez Sánchez de la Blanca, César Octavio; Zimmermann, Frank

    2014-01-01

    The Large Hadron Collider (LHC) is the world’s largest and most powerful particle collider. Its main objectives are to explore the validity of the standard model of particle physics and to look for new physics beyond it, at unprecedented collision energies and rates. A good luminosity performance is imperative to attain these goals. In the last stage of the LHC commissioning (2011-2012), the limiting factor to achieving the design bunch spacing of 25 ns has been the electron cloud effects. The electron cloud is also expected to be the most important luminosity limitation after the first Long Shut-Down of the LHC (LS1), when the machine should be operated at higher energy and with 25-ns spacing, as well as for the planned luminosity upgrade (HL-LHC) and future high energy proton colliders (HE-LHC and VHE-LHC). This thesis contributes to the understanding of the electron cloud observations during the first run of the LHC (2010-2012), presents the first beam dynamics analysis for the next generation of high en...

  2. First electron-cloud studies at the Large Hadron Collider

    Directory of Open Access Journals (Sweden)

    O. Domínguez

    2013-01-01

    Full Text Available During the beam commissioning of the Large Hadron Collider (LHC [LHC Design Report No. CERN-2004-003-V-1, 2004 [http://cds.cern.ch/record/782076?ln=en]; O. Brüning, H. Burkhardt, and S. Myers, Prog. Part. Nucl. Phys. 67, 705 (2012PPNPDB0146-641010.1016/j.ppnp.2012.03.001] with 150, 75, 50, and 25-ns bunch spacing, important electron-cloud effects, like pressure rise, cryogenic heat load, beam instabilities, or emittance growth, were observed. Methods have been developed to infer different key beam-pipe surface parameters by benchmarking simulations and pressure rise as well as heat-load observations. These methods allow us to monitor the scrubbing process, i.e., the reduction of the secondary emission yield as a function of time, in order to decide on the most appropriate strategies for machine operation. To better understand the influence of electron clouds on the beam dynamics, simulations have been carried out to examine both the coherent and the incoherent effects on the beam. In this paper we present the methodology and first results for the scrubbing monitoring process at the LHC. We also review simulated instability thresholds and tune footprints for beams of different emittance, interacting with an electron cloud in field-free or dipole regions.

  3. Study of diffused particles by an electron cyclotron-resonance ions source plasma

    International Nuclear Information System (INIS)

    Klein, J.P.

    1995-01-01

    A double electrostatic analyser has been built mainly to study the loss cone electron population. The analysis of the ions can help to determine the plasma potential. The possibility of applying two analysing potentials along the extraction decaying magnetic filed allowed us to determine the anisotropy of the electron distribution function, of parallel temperature Tpar and perpendicular temperature Tper outside the plasma. The Tpar temperature remains constant at around 10 eV when Tper increases from 30 eV to 150 eV with improved confinement. The electron cyclotron heating provides mainly perpendicular energy to the electrons. The perpendicular electron energy is then converted to parallel energy predominantly by electron ion collisions and leave the plasma with a frequency depending on v per -3 . Taking a Maxwellian function of temperature T per cent to describe the electron function distribution f cent (v per ) in the center of the plasma is in line with the experimental electron characteristics obtained with a single electrostatic potential. Temperatures of 2 keV have been reached at 10 Ghz and 6 keV at 18 Ggz. Measurements of density and diamagnetism can complete the description of this warm population: the warm electrons dominate in number but leave the plasma quicker than the very hot electron population (analysed with the X ray diagnostic). For this reason the energy density of warm electrons is less than that of the very hot population by warm electrons consume most of the injected rf power. (author). 52 refs., 100 figs

  4. Pulse radiolysis studies on the release of cytotoxins from electron affinic anticancer prodrugs following their one-electron reduction

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, R.F.; Ware, D.C.; Denny, W.A.; Lee, H.; Tercel, M.; Wilson, W.R. [Auckland Univ. (New Zealand)

    1996-12-31

    New approaches to killing chemoresistant and radioresistant hypoxic cells of solid tumours include the selective release of potent cytotoxins from relatively non-toxic prodrugs through reductive metabolism and/or radiolytic reduction. Central to these studies, is an understanding of the mechanism of cytotoxin release and the basis of hypoxia-selectivity, since such information can be used to design compounds of high potency against solid tumours. Pulse radiolysis studies can offer unique insights into these underlying mechanisms in aqueous solution through the determination of thermodynamic one-electron reduction potentials of the prodrugs, rate constants for the formation and spectral charaterization of one-electron reduced prodrugs, the kinetics release of the cytotoxins from one-electron reduced prodrugs and the influence of molecular oxygen on the obligate radical intermediates. A series of different triggers, which are found to vary greatly in the rate constant for release of the effectors upon one-electron reduction of the prodrugs, will be discussed. Release of effector from a prodrug does not solely depend upon the type of trigger but can also be dependent on the type of linker and released effector. For example, whereas fast quantitative release of the mustard effector mechlorethamine is seen from the quaternary nitroimidazole upon one electron reduction, release of N-[2-(dimethylamino)ethyl] acridine-4-carboxamide (DACA), requires a higher level of reduction of the same trigger. Release of cytotoxic ligands from metal complexes requires that the metal centre is reduced. When the metal centre is lower than DACA bound as a ligand, reduction is seen to occur solely on the ligand without release from the metal centre. 1 ref., 1 fig.

  5. In Situ Transmission Electron Microscopy Study of Electron Beam-Induced Transformations in Colloidal Cesium Lead Halide Perovskite Nanocrystals

    Science.gov (United States)

    2017-01-01

    An increasing number of studies have recently reported the rapid degradation of hybrid and all-inorganic lead halide perovskite nanocrystals under electron beam irradiation in the transmission electron microscope, with the formation of nanometer size, high contrast particles. The nature of these nanoparticles and the involved transformations in the perovskite nanocrystals are still a matter of debate. Herein, we have studied the effects of high energy (80/200 keV) electron irradiation on colloidal cesium lead bromide (CsPbBr3) nanocrystals with different shapes and sizes, especially 3 nm thick nanosheets, a morphology that facilitated the analysis of the various ongoing processes. Our results show that the CsPbBr3 nanocrystals undergo a radiolysis process, with electron stimulated desorption of a fraction of bromine atoms and the reduction of a fraction of Pb2+ ions to Pb0. Subsequently Pb0 atoms diffuse and aggregate, giving rise to the high contrast particles, as previously reported by various groups. The diffusion is facilitated by both high temperature and electron beam irradiation. The early stage Pb nanoparticles are epitaxially bound to the parent CsPbBr3 lattice, and evolve into nonepitaxially bound Pb crystals upon further irradiation, leading to local amorphization and consequent dismantling of the CsPbBr3 lattice. The comparison among CsPbBr3 nanocrystals with various shapes and sizes evidences that the damage is particularly pronounced at the corners and edges of the surface, due to a lower diffusion barrier for Pb0 on the surface than inside the crystal and the presence of a larger fraction of under-coordinated atoms. PMID:28122188

  6. Study of tokamak plasma electron cyclotron emission during electron-wave interaction near the lower hybrid frequency

    International Nuclear Information System (INIS)

    Girard, A.

    1986-11-01

    The quasilinear theory of wave-particle interaction is presented. Diagnostic possibilities of electron cyclotron emission. To study the cyclotron radiation (whose wavelength is millimeter order), a Michelson type interferometer is used, which allows to select willingly the useful spectral field. The cyclotron radiation allows characterization of a pumping wave: in studying the spectrum part where plasma is optically thin the studied cyclotron emissivity is directly proportional to absorbed power by plasma. Saturation of power absorption by plasma has been observed and studied [fr

  7. Dynamic-scanning-electron-microscope study of friction and wear

    Science.gov (United States)

    Brainard, W. A.; Buckley, D. H.

    1974-01-01

    A friction and wear apparatus was built into a real time scanning electron microscope (SEM). The apparatus and SEM comprise a system which provides the capability of performing dynamic friction and wear experiments in situ. When the system is used in conjunction with dispersive X-ray analysis, a wide range of information on the wearing process can be obtained. The type of wear and variation with speed, load, and time can be investigated. The source, size, and distribution of wear particles can be determined and metallic transferal observed. Some typical results obtained with aluminum, copper, and iron specimens are given.

  8. Feasibility studies of microelectrode silicon detectors with integrated electronics

    International Nuclear Information System (INIS)

    Dalla Betta, G.-F.; Batignani, G.; Bettarini, S.; Boscardin, M.; Bosisio, L.; Carpinelli, M.; Dittongo, S.; Forti, F.; Giorgi, M.; Gregori, P.; Lusiani, A.; Manghisoni, M.; Pignatel, G.U.; Rama, M.; Ratti, L.; Re, V.; Sandrelli, F.; Speziali, V.; Svelto, F.; Zorzi, N.

    2002-01-01

    We describe our experience on design and fabrication, on high-resistivity silicon substrates, of microstrip detectors and integrated electronics, devoted to high-energy physics experiments and medical/industrial imaging applications. We report on the full program of our collaboration, with particular regards to the tuning of a new fabrication process, allowing for the production of good quality transistors, while keeping under control the basic detector parameters, such as leakage current. Experimental results on JFET and bipolar transistors are presented, and a microstrip detector with an integrated JFET in source-follower configuration is introduced

  9. Scanning electron microscopic study of apical and intracanal resorption.

    Science.gov (United States)

    Delzangles, B

    1989-07-01

    Apical radicular and intracanal surfaces of extracted teeth with apical lesions were examined by means of scanning electron microscopy. The distribution of apical and intracanal resorption areas varied with the presence of a granuloma or a cyst. Teeth bearing granulomas showed an apical resorption centered on the main foramina whereas the hard tissue underlying a cyst showed little or no resorption. Intracanal resorption was always marked in the apical third and more scattered in the middle and cervical third. The resorption disrupted the anatomical structures.

  10. Electron impact study of molecular ions of some benzyl derivatives

    International Nuclear Information System (INIS)

    Selim, E.T.; Rabia, M.A.; Fahmy, M.A.

    1992-01-01

    The ionization energies at threshold and values of higher energy levels for the molecular ions of benzyl alcohol, benzyl amine and benzyl cyanide are reported using electron impact technique. The first ionization energy values are found to be 8.26 eV (benzyl alcohol), 8.49 eV(benzyl amine)and 9.32 eV (benzyl cyanide). Some of the reported higher energy levels for the molecular ions are tentatively explained. The differences in the relative abundances for the main fragment ions are discussed and attributed to the effect of the different substituents - OH, -NH2 and -CN groups

  11. Electron back scattered diffraction study of SmCo magnets

    Energy Technology Data Exchange (ETDEWEB)

    Yonamine, T. [Divisao de Metrologia de Materiais-INMETRO, Av. Nossa Senhora das Gracas, 50 (Xerem), 25250-020 Duque de Caxias, RJ (Brazil)], E-mail: tyfukuhara@inmetro.gov.br; Fukuhara, M.; Machado, R. [Divisao de Metrologia de Materiais-INMETRO, Av. Nossa Senhora das Gracas, 50 (Xerem), 25250-020 Duque de Caxias, RJ (Brazil); Missell, F.P. [Divisao de Metrologia de Materiais-INMETRO, Av. Nossa Senhora das Gracas, 50 (Xerem), 25250-020 Duque de Caxias, RJ (Brazil); Departamento de Fisica e Quimica, Centro de Ciencias Exatas e Tecnologia, Universidade de Caxias do Sul, 95070-560 Caxias do Sul, RS (Brazil)

    2008-07-15

    The remanence and energy product of permanent magnets is a strong function of their crystallographic texture. Electron back scattered diffraction (EBSD) is a tool for texture analysis providing information about the atomic layers up to 50 nm below the surface of the material. This paper discusses experimental requirements for performing EBSD measurements on rare-earth permanent magnets and presents results on commercial SmCo magnet material. EBSD measurements proved to be very sensitive to misaligned grains and were sensitive to texture in good agreement with information provided by X-ray diffraction scans. Results for nanostructured Sm(CoFeCuZr){sub z} magnets are also discussed.

  12. Horner's syndrome: an electron microscopic study of a human iris.

    Science.gov (United States)

    McCartney, A. C.; Riordan-Eva, P.; Howes, R. C.; Spalton, D. J.

    1992-01-01

    Electron microscopy was performed on the irides of a man with a history of a long standing Horner's syndrome which resulted in iris heterochromia. Comparison of his normal brown iris with the depigmented blue iris showed depletion of anterior border cells and absence of sympathetic nerve fibres. Stromal melanocyte numbers were also diminished but melanosome numbers within the residual cells were not significantly different. Postnatal maintenance of stromal and anterior border zone pigmentation, derived from the neural crest, would appear to be dependent on an intact sympathetic nerve supply in contrast to the iris pigment epithelium which remains normally unaffected in Horner's syndrome. Images PMID:1486079

  13. Electron Paramagnetic Resonance Spectroscopy and Hall Effect Studies of the Effects of Low Energy Electron Irradiation on Gallium Nitride

    National Research Council Canada - National Science Library

    Greene, Kevin

    2003-01-01

    ... for 1.0 MeV electron irradiation have been ascertained by the concerted application of electron paramagnetic resonance spectroscopy and Hall effect measurements to virgin and electron-irradiated GaN epilayers...

  14. Electronic properties and Compton scattering studies of monoclinic tungsten dioxide

    International Nuclear Information System (INIS)

    Heda, N.L.; Ahuja, Ushma

    2015-01-01

    We present the first ever Compton profile measurement of WO 2 using a 20 Ci 137 Cs γ-ray source. The experimental data have been used to test different approximations of density functional theory in linear combination of atomic orbitals (LCAO) scheme. It is found that theoretical Compton profile deduced using generalized gradient approximation (GGA) gives a better agreement than local density approximation and second order GGA. The computed energy bands, density of states and Mulliken's populations (MP) data confirm a metal-like behavior of WO 2 . The electronic properties calculated using LCAO approach are also compared with those obtained using full potential linearized augmented plane wave method. The nature of bonding in WO 2 is also compared with isoelectronic WX 2 (X=S, Se) compounds in terms of equal-valence-electron-density profiles and MP data, which suggest an increase in ionic character in the order WSe 2 →WS 2 →WO 2 . - Highlights: • Presented first-ever Compton profile (CP) measurements on WO 2 . • Analyzed CP data in terms of LCAO–DFT calculations. • Discussed energy band, DOS and Mulliken's population. • Discussed equally scaled CPs and bonding of isoelectronic WO 2 , WS 2 and WSe 2 . • Reported metallic character and Fermi surface topology of WO 2

  15. Compton profile study and electronic properties of tantalum diboride

    International Nuclear Information System (INIS)

    Raykar, Veera; Bhamu, K.C.; Ahuja, B.L.

    2013-01-01

    We have reported the first-ever experimental Compton profile (CP) of TaB 2 using 20 Ci 137 Cs Compton spectrometer. To compare the experimental data, we have also computed the theoretical CPs using density functional theory (DFT) and hybridization of DFT and Hartree–Fock (HF) within linear combination of the atomic orbitals (LCAO) method. In addition, we have reported energy bands and density of states of TaB 2 using LCAO and full potential-linearized augmented plane wave (FP-LAPW) methods. A real space analysis of CP of TaB 2 confirms its metallic character which is in tune with the cross-overs of Fermi level by energy bands and Fermi surface topology. A comparison of equal-valence-electron-density (EVED) experimental profiles of isoelectronic TaB 2 and NbB 2 show more covalent (or less ionic) character of TaB 2 than that of NbB 2 which is in agreement with available ionicity data. - Highlights: ► Reported first-ever experimental Compton profile (CP) of TaB 2 . ► Interpreted experimental CP using theoretical CP within density functional theory. ► Analyzed equal-valence-electron-density experimental CPs of TaB 2 and NbB 2 . ► Established metallic character by taking Fourier transform of experimental CP. ► Reported energy bands, DOS and Fermi surface of TaB 2 using LCAO and FP-LAPW

  16. Power electronic converters modeling and control with case studies

    CERN Document Server

    Bacha, Seddik; Bratcu, Antoneta Iuliana

    2014-01-01

    Modern power electronic converters are involved in a very broad spectrum of applications: switched-mode power supplies, electrical-machine-motion-control, active power filters, distributed power generation, flexible AC transmission systems, renewable energy conversion systems and vehicular technology, among them. Power Electronics Converters Modeling and Control teaches the reader how to analyze and model the behavior of converters and so to improve their design and control. Dealing with a set of confirmed algorithms specifically developed for use with power converters, this text is in two parts: models and control methods. The first is a detailed exposition of the most usual power converter models: ·        switched and averaged models; ·        small/large-signal models; and ·        time/frequency models. The second focuses on three groups of control methods: ·        linear control approaches normally associated with power converters; ·        resonant controllers b...

  17. A coordinated two-satellite study of energetic electron precipitation events

    International Nuclear Information System (INIS)

    Imhof, W.L.; Nakano, G.H.; Gaines, E.E.; Reagan, J.B.

    1975-01-01

    A new technique for studying the spatial/temporal variations of energetic electron precipitation events is investigated. Data are presented in which precipitating electrons were measured simultaneously on two coordinated polar-orbiting satellites and the bremsstrahlung produced by the electrons precipitating into the atmosphere was observed from one of the satellites. Two electron spectrometers measuring the intensities and energy spectra of electrons of >130 keV were located on the oriented satellite 1971-089A (altitude, approx. =800 km), whereas a single similar spectrometer measuring electrons of >160 keV was located on the spinning low-altitude (approx.750 km) satellite 1972-076B. The X rays of >50 keV were measured with a 50-cm 3 germanium spectrometer placed on the 1972-076B satellite. With the coordinated data a study is made of events in which large fluctuations were observed in the precipitating energetic electron intensities. In the examples presented the satellite X ray data alone demonstrate that the spatially integrated electron influx was constant in time, and when the X ray data are combined with the direct electron measurements from the two satellites, the resulting data suggest that the major features in the flux profiles were primarily spatial in nature. The combination of X ray and electron measurements from two satellites is shown to provide an important method for studying and attempting to resolve spatial and temporal effects

  18. Development of two electronic bladder diaries: a patient and healthcare professionals pilot study.

    Science.gov (United States)

    Mangera, Altaf; Marzo, Alberto; Heron, Nicola; Fernando, Dayan; Hameed, Khawar; Soliman, Abdel-Hamid A; Bradley, Mike; Hosking, Ian; Abdel-Maguid, Mohamed; Levermore, Martin; Tindale, Wendy B; Chapple, Christopher

    2014-09-01

    Assess patients' preferences in a pilot crossover study of two different electronic voiding diaries against a standard paper diary. Assess urological health professional (HP) opinions on the electronic bladder diary reporting system. Two different electronic diaries were developed: (1) electronically read diary-a card with predefined slots read by a card reader and (2) e-diary-a handheld touch screen device. Data uploaded from either electronic diary produced an electronic report. We recruited 22 patients split into two cohorts for each electronic diary, 11 completed each type of electronic diary for 3 days either preceded or followed by a standard paper diary for 3 days. Both diaries were completed on the 7th day. Patients' perceptions of both diaries were recorded using a standardized questionnaire. A HP study recruited 22 urologists who were given the paper diary and the electronic reports. Time taken for analysis was recorded along with accuracy and HP preferences. The majority of patients (82%) preferred the e-diary and only 1/11 found it difficult to use. Patients had the same preference for the electronically read diary as the paper diary. The paper diary took 66% longer to analyze than the electronic report (P analyzed with an accuracy of 58% compared to 100%. Slightly more HP (9%) preferred the electronic report to the paper diary. This proposed e-diary with its intuitive interface has overcome previous deficiencies in electronic diaries with most patients finding the format user-friendly. Electronic reports make analysis and interpretation by HP quicker and more accurate. © 2013 Wiley Periodicals, Inc.

  19. Status of experimental studies of electron cloud effects at the Los Alamos proton storage ring

    Energy Technology Data Exchange (ETDEWEB)

    Macek, R. J. (Robert J.); Browman, A. A. (Andrew A.); Borden, M. J. (Michael J.); Fitzgerald, D. H. (Daniel H.); McCrady, R. C. (Rodney C.); Spickermann, T. J. (Thomas J.); Zaugg, T. J. (Thomas J.)

    2004-01-01

    Various electron cloud effects (ECE) including the two-stream (e-p) instability at the Los Alamos Proton Storage Ring (PSR) have been studied extensively for the past five years with the goal of understanding the phenomena, mitigating the instability and ultimately increasing beam intensity. The specialized diagnostics used in the studies are two types of electron detectors, the retarding field analyzer and the electron sweepmg detector - which have been employed to measure characteristics of the electron cloud as functions of time, location in the ring and various influential beam parameters - plus a short stripline beam position monitor used to measure high frequency motion of the beam centroid. Highlights of this research program are summarized along with more detail on recent results obtained since the ECLOUD'02 workshop. Recent work mcludes a number of parametric studies of the various factors that affect the electron cloud signals, studies of the sources of initial or 'seed' electrons, additional observations of electron cloud dissipation after the beam pulse is extracted, studies of the 'first pulse instability' issue, more data on electron suppression as a cure for the instability, and observations of the effect of a one-turn weak kick on intense beams in the presence of a significant electron cloud.

  20. In-situ studies on phase transformations under electron irradiation in ...

    Indian Academy of Sciences (India)

    High voltage electron microscopy (HVEM), using electron energies adequate for causing displacements of atoms from lattice sites, is a very effective technique for studying mechanisms of solid state phase transformations and for charting the path of phase evolution in real time. This has been demonstrated in studies on ...

  1. Comparison between electron and neutron Compton scattering studies

    Directory of Open Access Journals (Sweden)

    Moreh Raymond

    2015-01-01

    Full Text Available We compare two techniques: Electron Compton Scattering (ECS and neutron Compton scattering (NCS and show that using certain incident energies, both can measure the atomic kinetic energy of atoms in molecules and solids. The information obtained is related to the Doppler broadening of nuclear levels and is very useful for deducing the widths of excited levels in many nuclei in self absorption measurements. A comparison between the atomic kinetic energies measured by the two methods on the same samples is made. Some results are also compared with calculated atomic kinetic energies obtained using the harmonic approximation where the vibrational frequencies were taken from IR/Raman optical measurements. The advantages of the ECS method are emphasized.

  2. A study about neutron sources for electron linear acceleractors

    International Nuclear Information System (INIS)

    Goncalez, O.L.

    1982-01-01

    The efficiency of neutron production and residual activity induced by electron incidence from 30 to 200 MeV on thick metalic targets of Al, Sb, Cu, Ir, Hg, Mo, Nb, Ni, Pd, Pt, Ta, Ti, W and Zr is evaluated. As a result of this evaluation, the tantalum, copper and antimony targets are indicated as the more suitable, representating high, low and medium atomic numbers. For the experimental part the Ti, Cu, Nb and Pb were selected as set representatives. The yield measured by the residual activities agree with theoretical calculation. The neutron angular distribution for niobium was measured by indium foil activation. In addition, some general features for 120 0 Cu and Nb spectra were obtained. (Author) [pt

  3. Electronic structure of lanthanum sesquioxide: A Compton scattering study

    Science.gov (United States)

    Sharma, Sonu; Sahariya, Jagrati; Arora, Gunjan; Ahuja, B. L.

    2014-10-01

    We present the first-ever experimental and theoretical momentum densities of La2O3. The Compton line shape is measured using a 20 Ci 137Cs Compton spectrometer at an intermediate resolution with full width at half maximum of 0.34 a.u. The experimental Compton profile is compared with the theoretical electron momentum densities computed using linear combination of atomic orbitals (LCAO) method with density functional theory (DFT). It is seen that the generalized gradient approximation (GGA) within DFT reconciles better with the experiment than other DFT based approximations, validating the GGA approximation for rare-earth sesquioxides. The energy bands and density of states computed using LCAO calculations show its wide band gap nature which is in tune with the available reflectivity and photo-absorption data. In addition, Mulliken's population and charge density are also computed and discussed.

  4. Electronic structure of lanthanum sesquioxide: A Compton scattering study

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, Sonu [Department of Physics, M.L. Sukhadia University, Udaipur 313001, Rajasthan (India); Sahariya, Jagrati [Department of Physics, Manipal University Jaipur, Jaipur 303007, Rajasthan (India); Arora, Gunjan [Department of Physics, Geetanjali Institute of Technical Studies, Udaipur 313022, Rajasthan (India); Ahuja, B.L., E-mail: blahuja@yahoo.com [Department of Physics, M.L. Sukhadia University, Udaipur 313001, Rajasthan (India)

    2014-10-01

    We present the first-ever experimental and theoretical momentum densities of La{sub 2}O{sub 3}. The Compton line shape is measured using a 20 Ci {sup 137}Cs Compton spectrometer at an intermediate resolution with full width at half maximum of 0.34 a.u. The experimental Compton profile is compared with the theoretical electron momentum densities computed using linear combination of atomic orbitals (LCAO) method with density functional theory (DFT). It is seen that the generalized gradient approximation (GGA) within DFT reconciles better with the experiment than other DFT based approximations, validating the GGA approximation for rare-earth sesquioxides. The energy bands and density of states computed using LCAO calculations show its wide band gap nature which is in tune with the available reflectivity and photo-absorption data. In addition, Mulliken's population and charge density are also computed and discussed.

  5. Electron microscopic study on SrGdMnO4

    International Nuclear Information System (INIS)

    Nakano, Hiromi; Ishizawa, Nobuo; Kamegashira, Naoki; Zulhadjri; Shishido, Toetsu

    2006-01-01

    Single crystals of SrGdMnO 4 have been synthesized by the floating zone method. The structure was characterized as the K 2 NiF 4 -type, using X-ray diffraction (XRD) and a transmission electron microscope (TEM). Presence of weak reflections breaking the archetypal tetragonal symmetry was observed from the selected area diffraction (SAD). The compound was found to have an orthorhombic unit cell of a ≅ b = 0.532(4) nm, c = 1.271(6) nm, by taking the a and b axes along the diagonal directions on the basal plane of the tetragonal archetype. Structural change occurred around 1018 K. The weak reflections disappeared in the SAD pattern, suggesting that crystal is of the archetype above 1018 K

  6. Electronic Cigarette and Electronic Hookah: A Pilot Study Comparing Two Vaping Products.

    Science.gov (United States)

    Dube, Shanta R; Pathak, Sarita; Nyman, Amy L; Eriksen, Michael P

    Since the introduction of e-cigarettes into the U.S. market, the number and variety of vaping products has proliferated. E-hookahs are long, pen-like vaping devices that debuted in U.S. markets in 2014. By applying the Host, Agent, Vector, Environment (HAVE) Model, the objective of this exploratory study was to assess differences between e-cigarettes and e-hookahs to help inform tobacco regulatory science and practice. In June-August 2014, a total of 54 unique manufactured e-cigarette and e-hookah products were identified at point of sales (POS) around three college campuses in Southeast U.S. Documented characteristics included brand name, disposable, rechargeable, nicotine containing, packaging, and flavor type. Statistical analyses were conducted October to November 2014 to assess frequency and percent of product type across POS and specific characteristics. Among 54 products, 70.4% were e-cigarettes and 29.6% were e-hookahs. Across POS, drug stores and grocery stores carried e-cigarettes exclusively, while gas stations carried the greatest proportion of e-hookahs. Compared to e-hookahs, a greater proportion of e-cigarettes were non-disposable and contained nicotine; a greater proportion of e-hookahs came in fruit and other types of flavors compared to e-cigarettes. The present study suggests that e-cigarettes and e-hookahs differ by specific product characteristics and by places where they are sold. Despite these differences, the products are used for similar purposes warranting careful monitoring of industry manufacturing and marketing, because the safety of both products is still undetermined. Additional research is needed to understand the uptake and continued use of these products.

  7. Electronic Cigarette and Electronic Hookah: A Pilot Study Comparing Two Vaping Products☆

    Science.gov (United States)

    Dube, Shanta R.; Pathak, Sarita; Nyman, Amy L.; Eriksen, Michael P.

    2015-01-01

    Since the introduction of e-cigarettes into the U.S. market, the number and variety of vaping products have proliferated. E-hookahs are long, pen-like vaping devices that debuted in U.S. markets in 2014. By applying the Host, Agent, Vector, Environment (HAVE) model, the objective of this exploratory study was to assess differences between e-cigarettes and e-hookahs to help inform tobacco regulatory science and practice. In June–August 2014, a total of 54 unique manufactured e-cigarette and e-hookah products were identified at point of sales (POS) around three college campuses in Southeast U.S. Documented characteristics included brand name, disposable, rechargeable, nicotine containing, packaging, and flavor type. Descriptive analyses were conducted October to November 2014 to assess frequency and percent of product type across POS and specific characteristics. Among 54 products, 70.4% was e-cigarettes and 29.6% was e-hookahs. Across POS, drug stores and grocery stores carried e-cigarettes exclusively, while gas stations carried the greatest proportion of e-hookahs. Compared to e-hookahs, a greater proportion of e-cigarettes were non-disposable and contained nicotine; a greater proportion of e-hookahs came in fruit and other types of flavors compared to e-cigarettes. The present study suggests that e-cigarettes and e-hookahs differ by specific product characteristics and by places where they are sold. Despite these differences, the products are used for similar purposes warranting careful monitoring of industry manufacturing and marketing, because the safety of both products is still undetermined. Additional research is needed to understand the uptake and continued use of these products. PMID:26740911

  8. Electronic Cigarette and Electronic Hookah: A Pilot Study Comparing Two Vaping Products

    Directory of Open Access Journals (Sweden)

    Shanta R. Dube

    2015-01-01

    Full Text Available Since the introduction of e-cigarettes into the U.S. market, the number and variety of vaping products have proliferated. E-hookahs are long, pen-like vaping devices that debuted in U.S. markets in 2014. By applying the Host, Agent, Vector, Environment (HAVE model, the objective of this exploratory study was to assess differences between e-cigarettes and e-hookahs to help inform tobacco regulatory science and practice. In June–August 2014, a total of 54 unique manufactured e-cigarette and e-hookah products were identified at point of sales (POS around three college campuses in Southeast U.S. Documented characteristics included brand name, disposable, rechargeable, nicotine containing, packaging, and flavor type. Descriptive analyses were conducted October to November 2014 to assess frequency and percent of product type across POS and specific characteristics. Among 54 products, 70.4% was e-cigarettes and 29.6% was e-hookahs. Across POS, drug stores and grocery stores carried e-cigarettes exclusively, while gas stations carried the greatest proportion of e-hookahs. Compared to e-hookahs, a greater proportion of e-cigarettes were non-disposable and contained nicotine; a greater proportion of e-hookahs came in fruit and other types of flavors compared to e-cigarettes. The present study suggests that e-cigarettes and e-hookahs differ by specific product characteristics and by places where they are sold. Despite these differences, the products are used for similar purposes warranting careful monitoring of industry manufacturing and marketing, because the safety of both products is still undetermined. Additional research is needed to understand the uptake and continued use of these products.

  9. Backscattered electron imaging and electron backscattered diffraction in the study of bacterial attachment to titanium alloy structure.

    Science.gov (United States)

    Wang, Anqi; Jones, Ian P; Landini, Gabriel; Mei, Junfa; Tse, Yau Y; Li, Yue X; Ke, Linnan; Huang, Yuanli; Liu, L I; Wang, Chunren; Sammons, Rachel L

    2018-04-01

    The application of secondary electron (SE) imaging, backscattered electron imaging (BSE) and electron backscattered diffraction (EBSD) was investigated in this work to study the bacterial adhesion and proliferation on a commercially pure titanium (cp Ti) and a Ti6Al4V alloy (Ti 64) with respect to substrate microstructure and chemical composition. Adherence of Gram-positive Staphylococcus epidermidis 11047 and Streptococcus sanguinis GW2, and Gram-negative Serratia sp. NCIMB 40259 and Escherichia coli 10418 was compared on cp Ti, Ti 64, pure aluminium (Al) and vanadium (V). The substrate microstructure and the bacterial distribution on these metals were characterised using SE, BSE and EBSD imaging. It was observed that titanium alloy-phase structure, grain boundaries and grain orientation did not influence bacterial adherence or proliferation at microscale. Adherence of all four strains was similar on cp Ti and Ti 64 surfaces whilst inhibited on pure Al. This work establishes a nondestructive and straight-forward statistical method to analyse the relationship between microbial distribution and metal alloy structure. © 2017 The Authors Journal of Microscopy © 2017 Royal Microscopical Society.

  10. Electron beam irradiation: laboratory and field studies of cowpea seeds

    International Nuclear Information System (INIS)

    Srinivasan, K.; Chauhan, S.K.; Prasad, T.V.; Pramod, R.; Verma, V.P.; Petwal, V.; Dwivedi, J.; Bhalla, S.

    2015-01-01

    Cowpea (Vigna unguiculata) rich in protein and vitamins is emerging as one of the most important food legumes to tackle malnutrition. Pulse beetles (Callosobruchus chinensis and C. maculatus) are the pests of economic importance causing enormous losses during storage. Although various pest management strategies exist for the control of these pests, environmental concerns necessitate developing ecofriendly strategies. Electron beam (EB) irradiation has the potential to be a viable, non-chemical, residue-free strategy for management of pulse beetles during storage, but higher doses affect seed germination and viability. Hence, the present investigation was taken up to analyse the dosage effect of the irradiation on seed attributes of cowpea. Healthy cowpea seeds were irradiated with low energy electrons at different doses viz., 180, 360, 540, 720, 900, 1080, 1260, 1440 and 1620 Gy at 500 keV using the EB Accelerator facility at Raja Ramanna Centre for Advanced Technology, Indore. EB irradiated seeds were tested for physiological viz., germination, seedling vigour and vigour index and biochemical parameters viz., electrical conductivity of seed leachate, seed viability/tetrazolium test and dehydrogenase activity. Germination and vigour of the irradiated seeds were evaluated as per the ISTA Rules (ISTA, 1996). Vigour index was calculated as the product of germination percentage and seedling vigour. About 3,000 irradiated seeds from each dose were grown in the field at the Experimental farm, National Bureau of Plant Genetic Resources, New Delhi. Seeds harvested from 1500 individual plants of M 1 generation from each dose (50 seeds from each plant individually) were sown in next season and observed for chlorophyll mutations, if any. Results revealed that doses upto 1080 Gy (88%) did not affect the germination of cowpea seeds drastically as compared to untreated seeds (98%). Lower doses viz., 180 and 360 Gy had no impact on vigour components while higher doses (1080 Gy

  11. Optical studies on electron beam evaporated Lithium Triborate films

    Science.gov (United States)

    Mohandoss, R.; Dhanuskodi, S.; Sanjeeviraja, C.

    2012-10-01

    Lithium triborate (LB3) has numerous applications in scintillator for neutron detection, laser weapon and communication. LB3 films have been prepared by electron beam evaporation technique under a pressure of 1 × 10-5 mbar on glass substrate at 323 K for 4 min. The crystallographic orientations and the lattice parameters (a = 8.55 (2); b = 5.09 (2); c = 7.39 (2) Å) were determined by powder XRD indicating the (1 1 1) preferential orientation of the film. The lower cut off wavelength at 325 nm with 75% transparency was measured from the UV-vis spectrum. The optical constants extinction coefficient (K), reflectance (R), the linear refractive index (1.34) and the optical energy band gap (˜4.0 eV) were estimated. The photoluminescence spectrum shows the emission peak in the visible region with low concentration of oxygen defects. LB3 is found to be second harmonic generation (SHG) active using a Q-switched Nd:YAG laser (1064 nm, 9 ns, 10 Hz). The nonlinear refractive index (n2 ˜ 10-16 cm2/W) and nonlinear absorption coefficient (β ˜ 10-2 cm/W) reveal (Z-scan technique) that the material has negative nonlinearity and self-focusing nature.

  12. A study of a few compounds with unpaired f electrons

    International Nuclear Information System (INIS)

    Soulie, Edgar.

    1977-07-01

    Ligand field theory is applied to compounds of uranium (V) (configuration f 1 ), uranium (IV) (f 2 ), and to hexagonal neodymium sesquioxide A-Nd 2 O 3 (f 3 ). The reinterpretation of the electronic absorption and paramagnetic resonance spectra of UF 6 Cs allows a determination of the spin-orbit coupling constant, the Newman intrinsic crystal field parameters, and the orbital angular momentum reduction factors, pointing to a degree of sigma covalence for the 5f orbitals. Raman diffusion and carbon 13 SMR spectra of U(NCS) 8 [N(C 2 H 5 ) 4 ] 4 dissolved in CD 3 NO 2 show that cubical coordination for uranium, known for the solid, is maintained in solution. Thermal variation of the magnetic susceptibility of this complex, quantitatively interpreted, leads to the description of the energy levels of f 2 configuration. For U(CH 3 -CO-CH-CO-CH 3 ) 4 the interpretation of the susceptibility curve results into the prediction of the susceptibility anisotropy, and the calculation of the unpaired spin density on the methin proton. Last, it was shown by proton magnetic resonance that U(CF 3 -CO-CH-CO-C 6 H 5 ) 4 behaves as a chemical shift reagent [fr

  13. Optical studies on electron beam evaporated lithium triborate films.

    Science.gov (United States)

    Mohandoss, R; Dhanuskodi, S; Sanjeeviraja, C

    2012-10-01

    Lithium triborate (LB3) has numerous applications in scintillator for neutron detection, laser weapon and communication. LB3 films have been prepared by electron beam evaporation technique under a pressure of 1×10(-5) mbar on glass substrate at 323 K for 4 min. The crystallographic orientations and the lattice parameters (a=8.55 (2); b=5.09 (2); c=7.39 (2)Å) were determined by powder XRD indicating the (111) preferential orientation of the film. The lower cut off wavelength at 325 nm with 75% transparency was measured from the UV-vis spectrum. The optical constants extinction coefficient (K), reflectance (R), the linear refractive index (1.34) and the optical energy band gap (~4.0 eV) were estimated. The photoluminescence spectrum shows the emission peak in the visible region with low concentration of oxygen defects. LB3 is found to be second harmonic generation (SHG) active using a Q-switched Nd:YAG laser (1064 nm, 9 ns, 10 Hz). The nonlinear refractive index (n(2)~10(-16) cm(2)/W) and nonlinear absorption coefficient (β~10(-2) cm/W) reveal (Z-scan technique) that the material has negative nonlinearity and self-focusing nature. Copyright © 2012 Elsevier B.V. All rights reserved.

  14. Electron spin resonance studies of carbonates and phosphates

    International Nuclear Information System (INIS)

    Seletchi, Emilia Dana

    2005-01-01

    Electron Spin Resonance (ESR) is an absolute dating technique suitable for the Quaternary, which can be applied to a wide range of archaeological and geological materials. This method is mostly used to date such things as calcium carbonate in limestone, stalactites, stalagmites, mollusk shells, and corals. The results show that and are the most commonly present radiation-induced defects in bicarbonates. A new methodology for the provenance of ancient monuments and artifacts was developed by using a large number of marble spectrum parameters. The sextet, dominant in the spectra, other peaks due to lattice defects, and organic radicals have been used in the persistent effort to characterize marble quarries. In ESR dating and dosimetry we can measure the intensity of an ESR signal and its enhancement by artificial irradiation with the absorbed dose. ESR retrospective dosimetry has proven to be a very useful technique for dose assessment in past radiation accidents. Human exposure can be determined directly from the ESR signal of tooth enamel. The majority of radiation-induced radicals in tooth enamel are carbonate derived: CO 2 - ; CO 3 - ; CO - ; CO 3 3- , but radicals derived from phosphate and oxygen were also identified. (author)

  15. Compton profile study and electronic properties of tantalum diboride.

    Science.gov (United States)

    Raykar, Veera; Bhamu, K C; Ahuja, B L

    2013-07-01

    We have reported the first-ever experimental Compton profile (CP) of TaB2 using 20 Ci(137)Cs Compton spectrometer. To compare the experimental data, we have also computed the theoretical CPs using density functional theory (DFT) and hybridization of DFT and Hartree-Fock (HF) within linear combination of the atomic orbitals (LCAO) method. In addition, we have reported energy bands and density of states of TaB2 using LCAO and full potential-linearized augmented plane wave (FP-LAPW) methods. A real space analysis of CP of TaB2 confirms its metallic character which is in tune with the cross-overs of Fermi level by energy bands and Fermi surface topology. A comparison of equal-valence-electron-density (EVED) experimental profiles of isoelectronic TaB2 and NbB2 show more covalent (or less ionic) character of TaB2 than that of NbB2 which is in agreement with available ionicity data. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Nanomaterial engineering and property studies in a transmission electron microscope.

    Science.gov (United States)

    Golberg, Dmitri; Costa, Pedro M F J; Wang, Ming-Sheng; Wei, Xianlong; Tang, Dai-Ming; Xu, Zhi; Huang, Yang; Gautam, Ujjal K; Liu, Baodan; Zeng, Haibo; Kawamoto, Naoyki; Zhi, Chunyi; Mitome, Masanori; Bando, Yoshio

    2012-01-10

    Modern methods of in situ transmission electron microscopy (TEM) allow one to not only manipulate with a nanoscale object at the nanometer-range precision but also to get deep insights into its physical and chemical statuses. Dedicated TEM holders combining the capabilities of a conventional high-resolution TEM instrument and atomic force -, and/or scanning tunneling microscopy probes become the powerful tools in nanomaterials analysis. This progress report highlights the past, present and future of these exciting methods based on the extensive authors endeavors over the last five years. The objects of interest are diverse. They include carbon, boron nitride and other inorganic one- and two-dimensional nanoscale materials, e.g., nanotubes, nanowires and nanosheets. The key point of all experiments discussed is that the mechanical and electrical transport data are acquired on an individual nanostructure level under ultimately high spatial, temporal and energy resolution achievable in TEM, and thus can directly be linked to morphological, structural and chemical peculiarities of a given nanomaterial. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  17. Production and Studies of Photocathodes for High Intensity Electron Beams

    CERN Document Server

    Chevallay, E; Legros, P; Suberlucq, Guy; Trautner, H

    2000-01-01

    For short, high-intensity electron bunches, alkali-tellurides have proved to be a reliable photo-cathode material. Measurements of lifetimes in an rf gun of the CLIC Test Facility II at field strengths greater than 100 MV/m are presented. Before and after using them in this gun, the spectral response of the CS-Te and Rb-Te cathodes were determined with the help of an optical parametric oscillator. The behaviour of both materials can be described by Spicer's 3-step model. Whereas during the use the threshold for photo-emission in Cs-Te was shifted to higher proton energies, that of Rb-Te did not change. Our latest investigations on the stoichiometric ratio of the components are shown. The preparation of the photo-cathodes was monitored with 320 nm wavelength light , with the aim of improving the measurement sensitivity. The latest results on the protection of Cs-Te cathode surfaces with CsBr against pollution are summarized. New investigations on high mean current production are presented.,

  18. The combined field emission-spin trapping method for studying reactions of electrons in organic solutions

    International Nuclear Information System (INIS)

    Noda, Shoji; Ohta, Yasunari; Yoshida, Hiroshi

    1979-01-01

    The reactions of electrons injected by field emission into solutions have been investigated. Free radicals generated by the dissociative electron attachment to chlorinated solutes in benzene solutions were detected by the spin trapping-ESR method, using pentamethylnitrosobenzene as a spin trapping agent. Nondissociative electron attachment to styrene caused by the field emission was also evidenced by detecting the α-methylbenzyl radical generated secondarily from the styrene radical anion. The electrons field-emitted into the solutions are captured almost quantitatively by the electron scavenging solutes. The field emission method has been found to be useful for generating authentically free radicals and for studying the anionic reaction induced by electrons without interference of countercations and of any reaction intermediates from solvent molecules. As an example of the chemical utilization of the field emission technique, the ESR parameters of the spin adducts of several hydrocarbon radicals have been collected by this technique. (author)

  19. Studies on fast electron transport in the context of fast ignition

    International Nuclear Information System (INIS)

    Batani, D.

    2011-01-01

    This paper deals with the problem of fast electron propagation in plasmas, in the context of the fast ignition (FI) approach to inertial confinement fusion (ICF). In FI, a short-pulse high-intensity laser beam should generate a beam of relativistic electrons, which propagate into the compressed pellet, depositing energy and igniting the fuel. The study of electron propagation in dense matter is hence essential to the success of this scheme. The propagation of relativistic electrons in dense matter is determined by collisions of fast electrons with ions and electrons in the material, which can be described in terms of stopping power, but it also depends on self-generated magnetic and electric fields, which play a major, or even dominant role. In this paper we will show the importance of such collective effects by discussing several experimental examples. (author)

  20. Atomic and molecular photoelectron and Auger-electron-spectroscopy studies using synchrotron radiation

    International Nuclear Information System (INIS)

    Southworth, S.H.

    1982-01-01

    Electron spectroscopy, combined with synchrotron radiation, was used to measure the angular distributions of photoelectrons and Auger electrons from atoms and molecules as functions of photon energy. The branching ratios and partial cross sections were also measured in certain cases. By comparison with theoretical calculations, the experimental results are interpreted in terms of the characteristic electronic structure and ionization dynamics of the atomic or molecular sample. The time structure of the synchrotron radiation source was used to record time-of-flight (TOF) spectra of the ejected electrons. The double-angle-TOF method for the measurement of photoelectron angular distributions is discussed. This technique offers the advantages of increased electron collection efficiency and the elimination of certain systematic errors. An electron spectroscopy study of inner-shell photoexcitation and ionization of Xe, photoelectron angular distributions from H 2 and D 2 , and photoionization cross sections and photoelectron asymmetries of the valence orbitals of NO are reported

  1. Study on Effects of Electron Donors on Phosphine Production from Anaerobic Activated Sludge

    Directory of Open Access Journals (Sweden)

    Jianping Cao

    2017-07-01

    Full Text Available The effects of different types and concentrations of electron donors (glucose, starch, methanol and sodium acetate on the formation of phosphine from anaerobic activated sludge that has been domesticated for a prolonged period were studied in small batch experiments. The results show that types and concentrations of electron donor have significant effects on the production of phosphine from anaerobic activated sludge. Among them, glucose was the most favourable electron donor, whereas sodium acetate was the least favourable electron donor for the removal of phosphorus and the production of phosphine. Higher concentrations of electron donors were more favourable for the reduction of phosphate into phosphine, and supplying more than nine times the amount of electron donor as theoretically required for the reduction of phosphate into phosphine was favourable for the production of phosphine.

  2. Studies of dynamics of electron clouds in STAR silicon drift detectors

    CERN Document Server

    Bellwied, R; Brandon, N; Caines, H; Chen, W; Dimassimo, D; Dyke, H; Hall, J R; Hardtke, D; Hoffmann, G W; Humanic, T J; Kotova, A I; Kotov, I V; Kraner, H W; Li, Z; Lynn, D; Middelkamp, P; Ott, G; Pandey, S U; Pruneau, C A; Rykov, V L; Schambach, J; Sedlmeir, J; Sugarbaker, E R; Takahashi, J; Wilson, W K

    2000-01-01

    The dynamics of electrons generated in silicon drift detectors was studied using an IR LED. Electrons were generated at different drift distances. In this way, the evolution of the cloud as a function of drift time was measured. Two methods were used to measure the cloud size. The method of cumulative functions was used to extract the electron cloud profiles. Another method obtains the cloud width from measurements of the charge collected on a single anode as a function of coordinate of the light spot. The evolution of the electron cloud width with drift time is compared with theoretical calculations. Experimental results agreed with theoretical expectations.

  3. Accelerating field spectrometer for photons and electrons simultaneous measurement. Application to decay schemes study

    International Nuclear Information System (INIS)

    Busani, Jean.

    1982-09-01

    An original spectrometer was built to improve the measurement of the absolute emission intensities of radionuclides with converted low energy gamma transitions. In this spectrometer, the same Si(Li) detector simultaneously measures electrons and photons emitted by the studied radionuclide; an electrostatic field may be established between the source and the detector to modify the electrons energy. This field allows the electron and photon peaks to be separated, and the absorption and energy straggling by detector windows to be decreased. Special attention has been given to determine spectrometer efficiency calibration curves for electrons and photons. 147 Nd and 133 Ba were used to test the spectrometer improvement and the method used [fr

  4. Solvation of the electron in alcohols studied using the Argonne picosecond pulse radiolysis system

    International Nuclear Information System (INIS)

    Jonah, C.D.; Kenney-Wallace, G.A.

    1979-01-01

    With a stroboscopic pulse radiolysis system, it is possible to measure the reactions of solvated electrons and dry electrons and the solvation time of electrons in alcohols from 20 psec to 350 psec. The solvation in alcohol and alcohol-alkane solutions is a complex process which depends on the microscopic structure of the fluid, so that the studies of solvation in alcohols as a function of temperature or as a function of the concentration of the alcohols must take into account the structure of the fluid being studied. The relaxation processes may not be dominant at low temperature. However, in room temperature alcohols, pre-existing traps are the dominant means of electron trapping. The extrapolation to water may be reasonable since water and alcohols both give similar final species. To obtain such idea of the solvation process in alcohols, the change of the absorption of electrons at 500 nm was measured. At very low concentration of alcohols in alkanes, electrons form a complex with a cluster of alcohol molecules, and the most probable size of this cluster is two alcohols (C 4 , C 10 ). The species formed is not solvated electrons, since the characteristic spectrum of solvated electrons is absent, and the conductivity of the species is far above that of solvated electrons. (Yamashita, S.)

  5. Internet User and Electronic Journals Perception: An Inservice Science Teacher Study

    Science.gov (United States)

    Nuangchalerm, Prasart

    2010-01-01

    The growth and diversity of electronic academic journals had been widely distributed. It can be made our beliefs that future electronic scholarly journals will be different from their print antecedents and that both will fill a different niche of user, and will be necessary for the growth of any field knowledge. This study aims to investigate…

  6. Electronic properties of diphenyl-s-tetrazine and some related oligomers. An spectroscopic and theoretical study

    Energy Technology Data Exchange (ETDEWEB)

    Moral, Monica; Garcia, Gregorio [Departamento de Quimica Fisica y Analitica, Facultad de Ciencias Experimentales, Universidad de Jaen, Campus las Lagunillas, E23071 Jaen (Spain); Penas, Antonio [Departamento de Quimica Inorganica y Organica, Facultad de Ciencias Experimentales, Universidad de Jaen, Campus las Lagunillas, E23071 Jaen (Spain); Garzon, Andres; Granadino-Roldan, Jose M. [Departamento de Quimica Fisica y Analitica, Facultad de Ciencias Experimentales, Universidad de Jaen, Campus las Lagunillas, E23071 Jaen (Spain); Melguizo, Manuel [Departamento de Quimica Inorganica y Organica, Facultad de Ciencias Experimentales, Universidad de Jaen, Campus las Lagunillas, E23071 Jaen (Spain); Fernandez-Gomez, Manuel, E-mail: mfg@ujaen.es [Departamento de Quimica Fisica y Analitica, Facultad de Ciencias Experimentales, Universidad de Jaen, Campus las Lagunillas, E23071 Jaen (Spain)

    2012-10-26

    Highlights: Black-Right-Pointing-Pointer We study properties of Ph{sub 2}Tz and (PhTz){sub n}Ph as candidates for organic electronics. Black-Right-Pointing-Pointer The synthesis of Ph{sub 2}Tz was performed through a modified Pinner-type reaction. Black-Right-Pointing-Pointer IR/Raman spectra allowed to conclude that Ph{sub 2}Tz is nearly planar in liquid phase. Black-Right-Pointing-Pointer Electronic structure was studied by UV-Vis/TD-DFT methods in different solvents. Black-Right-Pointing-Pointer Bandgap, E{sub LUMO}, electron mobility predict some n-type character for limit polymer. -- Abstract: This work presents a theoretical and spectroscopic study on the electronic and structural properties of the diphenyl-s-tetrazine molecule (Ph{sub 2}Tz) and some oligomeric derivatives. Ph{sub 2}Tz was synthesized through a variation of Pinner-type reaction which uses N-acetylcysteine as catalyst. Insight into the structure and electronic properties of the title compound was obtained through IR, Raman, UV-Vis spectra in different solvents, and theoretical calculations. Theoretical studies have been extended to different n-mers derivatives up to an ideal molecular wire through the oligomeric approximation, predicting this way electronic properties such as LUMO energy levels, electron affinity and reorganization energy in order to assess their possible applications in molecular electronics.

  7. Photosynthetic electron transport in purple bacteria: An in vivo spectroscopic study

    OpenAIRE

    BÍNA, David

    2009-01-01

    Electron transport in purple bacteria was studied using combination of absorption spectroscopy and induced bacteriochlorophyll fluorescence in whole cells in vivo. Focus is placed on relations between fluorescence yield, the state of the electron transport chain and the membrane potential. A laboratory-built absorption spectrophotometer-fluorimeter is described.

  8. Electron transport and nonlinear optical properties of substituted aryldimesityl boranes: a DFT study.

    Directory of Open Access Journals (Sweden)

    Altaf Hussain Pandith

    Full Text Available A comprehensive theoretical study was carried out on a series of aryldimesityl borane (DMB derivatives using Density Functional theory. Optimized geometries and electronic parameters like electron affinity, reorganization energy, frontiers molecular contours, polarizability and hyperpolarizability have been calculated by employing B3PW91/6-311++G (d, p level of theory. Our results show that the Hammett function and geometrical parameters correlates well with the reorganization energies and hyperpolarizability for the series of DMB derivatives studied in this work. The orbital energy study reveals that the electron releasing substituents increase the LUMO energies and electron withdrawing substituents decrease the LUMO energies, reflecting the electron transport character of aryldimesityl borane derivatives. From frontier molecular orbitals diagram it is evident that mesityl rings act as the donor, while the phenylene and Boron atom appear as acceptors in these systems. The calculated hyperpolarizability of secondary amine derivative of DMB is 40 times higher than DMB (1. The electronic excitation contributions to the hyperpolarizability studied by using TDDFT calculation shows that hyperpolarizability correlates well with dipole moment in ground and excited state and excitation energy in terms of the two-level model. Thus the results of these calculations can be helpful in designing the DMB derivatives for efficient electron transport and nonlinear optical material by appropriate substitution with electron releasing or withdrawing substituents on phenyl ring of DMB system.

  9. A scanning electron microscopic study of biliary stent materials

    NARCIS (Netherlands)

    van Berkel, A. M.; van Marle, J.; van Veen, H.; Groen, A. K.; Huibregtse, K.

    2000-01-01

    Clogging of biliary stents remains an important problem. In vitro studies have shown less sludge formation in Teflon stents. Recently, clinical studies with Teflon stents have produced contradictory results. The aim of this study was to investigate whether the surface properties of the

  10. The study of dynamics of electrons in the presence of large current densities

    International Nuclear Information System (INIS)

    Garcia, G.

    2007-11-01

    The runaway electron effect is considered in different fields: nuclear fusion, or the heating of the solar corona. In this thesis, we are interested in runaway electrons in the ionosphere. We consider the issue of electrons moving through an ionospheric gas of positive ions and neutrals under the influence of a parallel electric field. We develop a kinetic model of collisions including electrons/electrons, electrons/ions and electrons/neutrals collisions. We use a Fokker-Planck approach to describe binary collisions between charged particles with a long-range interaction. A computational example is given illustrating the approach to equilibrium and the impact of the different terms. Then, a static electric field is applied in a new sample run. In this run, the electrons move in the z direction, parallel to the electric field. The first results show that all the electron distribution functions are non-Maxwellian. Furthermore, runaway electrons can carry a significant part of the total current density up to 20% of the total current density. Nevertheless, we note that the divergence free of the current density is not conserved. We introduce major changes in order to take into account the variation of the different moments of the ion distribution functions. We observe that the electron distribution functions are still non-Maxwellian. Runaway electrons are created and carry the current density. The core distribution stay at rest. As these electrons undergo less collisions, they increase the plasma conductivity. We make a parametric study. We fit the electron distribution function by two Maxwellian. We show that the time to reach the maximal current density is a key point. Thus, when we increase this time, we modify the temperatures. The current density plays a primary role. When the current density increases, all the moments of the distributions increase: electron density and mean velocity of the suprathermal distribution and the electron temperature of the core and

  11. 5D simulation study of suprathermal electron transport in non-axisymmetric plasmas

    International Nuclear Information System (INIS)

    Murakami, S.; Idei, H.; Kubo, S.; Nakajima, N.; Okamoto, M.; Gasparino, U.; Maassberg, H.; Rome, M.; Marushchenko, N.

    1999-01-01

    ECRH-driven transport of suprathermal electrons is studied in non-axisymmetric plasmas using a new Monte Carlo simulation technique in 5D phase space. Two different phases of the ECRH-driven transport of suprathermal electrons can be seen; one is a rapid convective phase due to the direct radial motion of trapped electrons and the other is a slower phase due to the collisional transport. The important role of the radial transport of suprathermal electrons in the broadening of the ECRH deposition profile is clarified in W7-AS. The ECRH driven flux is also evaluated and put in relation with the 'electron root' feature recently observed in W7-AS. It is found that, at low collisionalities, the ECRH driven flux due to the suprathermal electrons can play a dominant role in the condition of ambipolarity and, thus, the observed 'electron root' feature in W7-AS is thought to be driven by the radial (convective) flux of ECRH generated suprathermal electrons. The possible scenario of this 'ECRH-driven electron root' is considered in the LHD plasma. (author)

  12. Construction of an electron accelerator of 20 KeV: application in the polymeric study

    International Nuclear Information System (INIS)

    Sandonato, G.M.

    1983-01-01

    A low energy electron accelerator (maximum energy 20 KeV) is constructed. A black and white kinescope electron gun, with a single thermionic emitter was used as electron source. The energy of electron beam can be changed continuously from 0 to 20 KeV. The intensity of the current can be changed from a minimum of 10 -12 A to a maximum of 3 μA, and can be mantained contant in time after its value has been fixed. The irradiated area can be changed from a diameter of 1 milimeter to a maximum of 6 centimeter, by focalizing or defocalizing the image of electron beam. The final pressure reached in vacuum chambers was 10 -7 Torr. During operation the surface of cathode of electron gun is damaged by ion bombardeament. The degree of damage can be checked if the cathode image is focalized and examined on a luminescent screen. The accelerator was used to study electron irradiation effects in Teflon, employing the method of the split Faraday cup. Transient charging and discharging currents were measured. The average range of electrons of the electrons and the induced conductivity were determined. (Author) [pt

  13. A multicentre, prospective, non-randomized, sequential, open-label trial to demonstrate the bioequivalence between intravenous immunoglobulin new generation (IGNG) and standard IV immunoglobulin (IVIG) in adult patients with primary immunodeficiency (PID).

    Science.gov (United States)

    Viallard, J-F; Brion, J-P; Malphettes, M; Durieu, I; Gardembas, M; Schleinitz, N; Hoarau, C; Lazaro, E; Puget, S

    2017-09-01

    To demonstrate the bioequivalence between 2 intravenous immunoglobulin (IVIG) preparations, TEGELINE ® and ClairYg ® , a ready-to-use 5% IVIG, in primary immunodeficiency (PID). Secondary objectives were to assess the efficacy, safety and pharmacokinetics of ClairYg ® . Twenty-two adult PID patients receiving stable doses of TEGELINE ® (5% lyophilized IVIG) were switched to ClairYg ® for 6 months. ClairYg ® was administered under the same conditions as TEGELINE ® , either every 3 or 4 weeks. The primary endpoint was mean average total IgG trough level at steady state with ClairYg ® versus TEGELINE ® . Clinical efficacy was also assessed in terms of infections and associated events. Bioequivalence was established with a mean average total IgG trough level at steady state being 8.05g/L with TEGELINE ® and 9.17g/L with ClairYg ® (i.e. geometric mean for the difference between ClairYg ® and TEGELINE ® was 1.136; [90% CI: 1.092-1.181] P4-6g/L) throughout the study. No patient was hospitalized for infection or had serious bacterial infections while receiving ClairYg ® . The median annualized infections rate per patient was similar for both products: 4.35 [0; 21.8] for TEGELINE ® and 4.30 [0; 15.1] for ClairYg ® . Infections were less common with higher IgG trough levels (>8.16g/L). ClairYg ® showed good safety, in particular good hepatic and renal tolerance, and did not induce hemolysis. ClairYg ® pharmacokinetics profile was comparable to that of TEGELINE ® . ClairYg ® is safe and effective in the treatment of adult PID. Copyright © 2017 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  14. Selectivity of alkyl radical formation from branched alkanes studied by electron spin resonance and electron spin echo spectroscopy

    International Nuclear Information System (INIS)

    Tsuneki, Ichikawa; Hiroshi, Yoshida

    1992-01-01

    Alkyl radicals generated from branched alkanes by γ radiation are being measuring by electron spin resonance and electron spin echo spectroscopy. This research is being conducted to determine the mechanism of selective alkyl radical formation in low-temperature solids

  15. Optical studies of MBE-grown InN nanocolumns: Evidence of surface electron accumulation

    Science.gov (United States)

    Segura-Ruiz, J.; Garro, N.; Cantarero, A.; Denker, C.; Malindretos, J.; Rizzi, A.

    2009-03-01

    Vertically self-aligned InN nanocolumns have been investigated by means of scanning electron microscopy, Raman scattering, and photoluminescence spectroscopy. Different nanocolumn morphologies corresponding to different molecular beam epitaxy growth conditions have been studied. Raman spectra revealed strain-free nanocolumns with high crystalline quality for the full set of samples studied. Longitudinal optical modes both uncoupled and coupled to an electron plasma coexist in the Raman spectra pointing to the existence of two distinctive regions in the nanocolumn: a surface layer of degenerated electrons and a nondegenerated inner core. The characteristics of the low-temperature photoluminescence and its dependence on temperature and excitation power can be explained by a model considering localized holes recombining with degenerated electrons close to the nonpolar surface. The differences observed in the optical response of different samples showing similar crystalline quality have been attributed to the variation in the electron accumulation layer with the growth conditions.

  16. Histological and electron microscopic study of the postulated ...

    African Journals Online (AJOL)

    Di(2-ethylhexyl)phthalate [DEHP] is a plasticizer (softener) used to increase the flexibility of polyvinyl chloride (plastic). Animal studies following acute and chronic exposure of DEHP show several toxic changes in many organs including the liver. There have been no studies of compound specific techniques for reducing ...

  17. Comparative study of the electronic structure of natural and synthetic ...

    Indian Academy of Sciences (India)

    ... have studied the Cr–K-edge XANES and EXAFS in natural Indian rubies from two sources and a synthetic ruby at ESRF. Weight % of various constituents in them is determined using EDAX measurements. Taking the results from the three techniques together we are able to demonstrate their feasibility in quantitative study ...

  18. Theoretical studies of inelastic molecule-surface and resonant electron-atom and electron-molecule scattering

    International Nuclear Information System (INIS)

    Mowrey, R.C. Jr.

    1985-01-01

    In part I, two problems in the inelastic scattering of molecules from nonvibrating surfaces are discussed. First, the close coupling (CC) method is used to study the orientational dependence of the transition probabilities for vibrationally and rotationally inelastic scattering of H 2 and N 2 from flat surfaces. The dependence of vibrational transition probabilities on the orientation of the molecule is strong but decreases as the energy increases. Second, a new approximation to the CC method for treating scattering of molecules from corrugated surfaces is discussed. The proposed local normal model of j/sub z/ conservation assumes that the component of the rotational angular momentum of the incident molecule which is parallel to the normal to the surface at the impact point is conserved during a collision. In part II, the use of the complex basis function method to study two shape resonances in electron scattering is discussed. The complex self-consistent-field (CSCF) method was used to obtain the position and width of the 2 D shape resonance in electron-calcium scattering. Comparison with experimental results shows that the lifetime is influenced by correlation effects. The CSCF and complex configuration interaction (CCI) methods were used to obtain the complex potential energy function for nuclear motion for the 2 Σ/sub u/ + resonance state of H 2 -

  19. Structure studies by electron microscopy and electron diffraction at Physics Department, University of Oslo, 1976-1985

    International Nuclear Information System (INIS)

    Gjoennes, J.K.; Olsen, A.

    1985-08-01

    The paper describes the reasearch activities and plans at the electron microscopy laboratorium, Physics Departmen, University of Oslo. Since the first electron microscope was installed in 1968, the research has covered inorganic structures, physical metallurgy, as well as theory of electron scattering and the development of methods in this field. The current plans involve efforts in the development of crystallographic and spectroscopic methods

  20. Pulse radiolytic studies of electron transfer processes and applications to solar photochemistry. Progress report

    Energy Technology Data Exchange (ETDEWEB)

    Neta, P.

    1995-02-01

    The pulse radiolysis technique is applied to the study of electron transfer processes in a variety of chemical systems. Reactive intermediates are produced in solution by electron pulse irradiation and the kinetics of their reactions are followed by time resolved absorption spectrophotometry. Complementary experiments are carried out with excimer laser flash photolysis. These studies are concerned with mechanisms, kinetics, and thermodynamics of reactions of organic and inorganic radicals and unstable oxidation states of metal ions. Reactions are studied in both aqueous and non-aqueous solutions. The studies focus on the unique ability of pulse radiolysis to provide absolute rate constants for reactions of many inorganic radicals and organic peroxyl radicals, species that are key intermediates in many chemical processes. A special concern of this work is the study of electron transfer reactions of metalloporphyrins, which permits evaluation of these molecules as intermediates in solar energy conversion. Metalloporphyrins react with free radicals via electron transfer, involving the ligand or the metal center, or via bonding to the metal, leading to a variety of chemical species whose behavior is also investigated. The highlights of the results during the past three years are summarized below under the following sections: (a) electron transfer reactions of peroxyl radicals, concentrating on the characterization of new peroxyl radicals derived from vinyl, phenyl, other aryl, and pyridyl; (b) solvent effects on electron transfer reactions of inorganic and organic peroxyl radicals, including reactions with porphyrins, and (c) electron transfer and alkylation reactions of metalloporphyrins and other complexes.