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Search Results: 1 - 10 of 161 matches for " Waller "
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Critical appraisal of biosimilar filgrastim (Nivestim ) for febrile and chemotherapy-induced neutropenia
Waller CF
Biosimilars , 2012, DOI: http://dx.doi.org/10.2147/BS.S17420
Abstract: itical appraisal of biosimilar filgrastim (Nivestim ) for febrile and chemotherapy-induced neutropenia Review (2364) Total Article Views Authors: Waller CF Published Date August 2012 Volume 2012:2 Pages 1 - 11 DOI: http://dx.doi.org/10.2147/BS.S17420 Received: 14 March 2012 Accepted: 02 June 2012 Published: 20 August 2012 Cornelius F Waller Freiburg University Medical Center, Department of Hematology/Oncology, Freiburg, Germany Abstract: Recombinant granulocyte colony-stimulating factor (filgrastim) stimulates the proliferation and differentiation of hematopoietic stem and progenitor cells committed to neutrophil and granulocyte lineages. Filgrastim has been used as an adjunct to chemotherapy for ameliorating neutropenia, one of the major side effects of chemotherapy in cancer patients. Its use has led to reduction of infections and hospital admissions for patients with cancer undergoing chemotherapy. In addition, filgrastim has multiple other indications in hematology and oncology. Following the European Union patent expiry of Neupogen (filgrastim; Amgen Inc) in 2006, a biosimilar filgrastim has been developed (Nivestim ; Hospira). In accordance with the requirements of the European Medicines Agency, Nivestim has been studied in a development program that included preclinical studies, two Phase I clinical trials, and one Phase III clinical study. Preclinical studies showed pharmacodynamic as well as pharmacokinetic bioequivalence with the original product, Neupogen. Two randomized, single-center, Phase I trials compared both the pharmacokinetic, pharmacodynamic, and safety profiles of Nivestim and Neupogen in healthy volunteers. In both studies, 90% confidence intervals for the primary endpoints were within the predefined range (0.80–1.25) necessary to demonstrate bioequivalence. Nivestim was well tolerated, with no additional safety concerns over Neupogen. Bioequivalence was demonstrated in a randomized, double-blind multicenter Phase III trial of 279 patients with breast cancer receiving myelosuppressive chemotherapy. The mean duration of severe neutropenia in cycle 1, the primary endpoint, was similar between Nivestim (1.6 days, n = 165) and Neupogen (1.3 days, n = 85), meeting predefined criteria for bioequivalence. Secondary endpoints supporting bioequivalence included the mean time to recovery of absolute neutrophil count and incidence of febrile neutropenia. The most common treatment-related adverse event with Nivestim was grade 1–2 bone pain. As a result of these preclinical and clinical trials, Nivestim was approved by the European Medicines Agency and in Australia for prevention of febrile neutropenia and treatment of neutropenia in cancer patients treated with cytotoxic chemotherapy (except in patients with myelodysplastic syndromes and chronic myelogenous leukemia). Nivestim is also indicated for the treatment of myelosuppression after bone marrow transplantation, of neutropenia in patients with human immunodeficiency virus, and of
Depositing Your Work in E-LIS: The Open Archive for Library and Information Science
Andrew Waller
Partnership : the Canadian Journal of Library and Information Practice and Research , 2006,
Abstract:
Beyond the Patriot Act: Rulings from the Office of Foreign Asset Control (OFAC) and their Effects on Canadian Libraries
Andrew Waller
Partnership : the Canadian Journal of Library and Information Practice and Research , 2006,
Abstract: OFAC is the Office of Foreign Assets Control, part of the UnitedStates Department of the Treasury. OFAC governs sanctions againstcountries embargoed by the United States and has released rulings thathave implications on the licenses signed by Canadian libraries and theprovision of information to library users. This paper investigates theeffects of the OFAC rulings and presents some suggestions for dealingwith these in the Canadian library community.
Beyond the Patriot Act: Rulings from the Office of Foreign Asset Control (OFAC) and their Effects on Canadian Libraries
Andrew Waller
Partnership : the Canadian Journal of Library and Information Practice and Research , 2006,
Abstract: OFAC is the Office of Foreign Assets Control, part of the United States Department of the Treasury. OFAC governs sanctions against countries embargoed by the United States and has released rulings that have implications on the licenses signed by Canadian libraries and the provision of information to library users. This paper investigates the effects of the OFAC rulings and presents some suggestions for dealing with these in the Canadian library community.
Depositing Your Work in E-LIS: The Open Archive for Library and Information Science
Andrew Waller
Partnership : the Canadian Journal of Library and Information Practice and Research , 2006,
Abstract:
Repeatability Estimates Of Sloped Scattered Data
Angelique Waller
Undergraduate Journal of Mathematical Modeling : One + Two , 2009, DOI: 10.5038/2326-3652.2.1.8
Abstract: Repeatability is the variance in data accumulated under fixed conditions. It is important for quality control as it costs both time and money to recalibrate tools and remanufacture machines. This project compares three methods for approximating the repeatability of a sloped scattered data set. The first method uses a linear approximation, the second involves rotating the data points, and the third calculates distance using right triangles. The methods are compared for both precision and ease of use.
L'integrazione delle pratiche di Sanitá Pubblica in Europa
H. Waller
Italian Journal of Public Health , 2003, DOI: 10.2427/6034
Abstract: Rilevanza dell’argomento: questo tema è diventato un importante problema di Sanità Pubblica anche in Europa. Studi epidemiologici mostrano che quasi tutti i problemi di salute e la prevalenza di malattie e di disabilità sono più frequenti negli strati sociali più bassi, indipendentemente dal modo in cui la classe sociale viene misurata (con qualche eccezione come ad esempio il cancro della mammella e le allergie). Inoltre, l’associazione tra svantaggio sociale e malattia è divenuta sempre più forte negli ultimi decenni (Marmot e Wilkinson, 1999). La rilevanza del tema è diventata ancora più grande dal momento che in molti Paesi candidati all’ingresso nell’Unione Europea sono frequenti povertà e disgregazione sociale (Mackenbach e Bakker, 2002). Future necessita’ di ricerca: in futuro, tutte le indagini nazionali sulla salute dovranno includere la classe sociale tra le variabili registrate regolarmente. La ricerca dovrà infatti concentrarsi sulla spiegazione della correlazione tra classe sociale e malattia usando studi longitudinali ed includendo fattori sociali, oltre a determinanti medico-sanitari. La correlazione tra classe sociale e la presenza di problemi di salute va studiata in entrambe le direzioni: un basso status sociale come determinante di malattia, come pure la presenza di problemi di salute come causa della discesa nella “scala sociale”. La pratica di Sanità Pubblica e lo sviluppo di politiche sociali devono affrontare adeguatamente entrambe le ipotesi.
“A garden in the middle of the sea”: Henry James’s The Aspern Papers and Transnational American Studies
Nicole Waller
Journal of Transnational American Studies , 2011,
Abstract: Nicole Waller’s study of Henry James’s The Aspern Papers examines how conventional literary studies’ approaches (those that depend on biography and character analysis) may tether James’s work to a set of values that reinscribe the hierarchies that his narrative specifically sets adrift. Reviewing various newer paradigms in American Studies—the border, immigrant studies, the Black Atlantic, Native American encounters—Waller relies on a subset of transnational studies, Atlantic studies, to utilize the metaphors of circulation and exchange, of fluidity and drift, of space and dislocation, to argue for a reading of James’s The Aspern Papers as a dislocated response to Nathaniel Hawthorne’s work The House of the Seven Gables. Reading The Aspern Papers closely against Hawthorne’s work, and comparing the European perspectives in both James’s and Hawthorne’s works, Waller suggests that in The Aspern Papers James affords a reading of the transnational experience as a generative gesture, where a Venetian “garden in the middle of the sea” may serve as an abode more fruitful (despite losses) and more productive than the fires to which Hawthorne condemns Italian villages in The Marble Faun. Waller’s interest in the fluid spaces between the works of James and Hawthorne is echoed by both transnational American Studies and the essay itself in the unnamed narrator’s instructions to the gondolier: “Go anywhere. . . .”
Recent b-physics results from OPAL
David Waller
Physics , 2003, DOI: 10.1140/epjcd/s2003-03-105-2
Abstract: The most recent b-physics results from the OPAL experiment at LEP are reviewed. A measurement of semileptonic B meson decays to narrow orbitally-excited charm mesons is presented first, followed by a study of charm production in b-hadron decays. Here, B refers to B+ and B0 mesons and their charge conjugates, and b-hadron refers to the admixture of hadrons containing a b quark produced in electron-positron annihilations at \sqrt{s}= m_Z.
Resistance to chemotherapy: What are the risks for the reindeer industry?
P. J. Waller
Rangifer , 1990,
Abstract: Although no drug resistance has been reported so far for parasites of reindeer, it would be unwise to assume that this situation will remain the same indefinitely. It is important to consider the principles of selection for resistance and plan ways of limiting these so that the emergence of resistance can be avoided.
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