812 research outputs found

    Ten years of biosimilar recombinant human growth hormone in Europe

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    Paul Saenger Division of Pediatric Endocrinology, Department of Pediatrics, Winthrop University Hospital, Mineola, NY, USA Abstract: Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. A biosimilar is defined by the European Medicines Agency (EMA) as a biological medicine that is similar to another biological medicine that has already been authorized for use. The EMA led the way (well ahead of the Food and Drug Administration in the US) in developing the biosimilar concept, and the type of science-based regulatory framework required to ensure high-quality, safe, and effective biosimilar medicines; the provisions for approval of biosimilars have been in place in Europe since 2005. Under these provisions, Omnitrope® was approved by the EMA in 2006 as the world’s first biosimilar medicine; 2016 therefore marks the 10th anniversary of its approval in Europe. A substantial data set, based on clinical development studies and 10 years of postapproval use, has now accumulated for biosimilar rhGH; this data set shows that the product is an effective treatment option for children who require rhGH treatment, and has a safety profile that is consistent with the rhGH class. The decade since the EMA approved biosimilar rhGH has seen the successful approval and clinical use of 20 biosimilar medicines, confirming the integrity of the scientific basis for the biosimilar concept, as well as the quality of regulatory decision-making. Keywords: recombinant human growth hormone, Omnitrope®, biosimila

    Linking entropy at rest with the underlying structural connectivity in the healthy and lesioned brain

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    The brain is a network that mediates information processing through a wide range of states. The extent of state diversity is a reflection of the entropy of the network. Here we measured the entropy of brain regions (nodes) in empirical and modeled functional networks reconstructed from resting state fMRI to address the connection of entropy at rest with the underlying structure measured through diffusion spectrum imaging. Using 18 empirical and 18 modeled stroke networks, we also investigated the effect that focal lesions have on node entropy and information diffusion. Overall, positive correlations between node entropy and structure were observed, especially between node entropy and node strength in both empirical and modeled data. Although lesions were restricted to one hemisphere in all stroke patients, entropy reduction was not only present in nodes from the damaged hemisphere, but also in nodes from the contralesioned hemisphere, an effect replicated in modeled stroke networks. Globally, information diffusion was also affected in empirical and modeled strokes compared with healthy controls. This is the first study showing that artificial lesions affect local and global network aspects in very similar ways compared with empirical strokes, shedding new light into the functional nature of stroke.In this work, G.D. was supported by the ERC Advanced Grant DYSTRUCTURE (n. 295129), by the Spanish Research Project PSI2016-75688-P (AEI/FEDER) and by the European Union’s Horizon 2020 research and innovation program under grant agreement n. 720270 (HBP SGA1). M.A. was supported by the ERC Advanced Grant DYSTRUCTURE (n. 295129). A.P.-A. was supported by a Juan de la Cierva fellowship (IJCI-2014–066) from the Spanish Ministry of Economy and Competitiveness. V.M.S. was supported by the Research Personnel Training program (PSI2013-42091-P) funded by the Spanish Ministry of Economy and Competitiveness

    Untersuchungen zur Strahlsimulation am MTU-Saenger-Heckmodell im TWG 1995.

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    Als Ergaenzung zu den reinen Ueberschallmessungen der DLR Koeln (TMK und H2K) am MTU-Saenger-Heckmodell zur Untersuchung der zweidimensionalen Treibstrahl-/Aussenstroemungsinterferenz wurden im TWG der DLR Goettingen Messungen im Transschall durchgefuehrt. Es wurden Druckverteilungen im Dueseninneren, der Duesenrampe und der Modell-/Klappenunterseite gemessen und in den beiden Formen p(x)/p0d und cp(x) (p0d &#61 Gesamtdruck im Triebwerkskanal) dargestellt. Diese Druckverteilungen wurden fuer einzelne Konturbereiche getrennt zu Kraft- und Momentenbeiwerten integriert und in geeigneter Weise zusammengefasst und praesentiert. Bei den drei Machzahlen Mach 0.9, 1.2 und 1.63 wurden jeweils zwei Duesendruckverhaeltnisse Eta &#61 p0d/p unendlich und die drei Anstellwinkel Alpha &#61 0 Grad, 2 Grad und 4 Grad betrachtet. Bei M &#61 1.63 wurde zusaetzlich Alpha &#61 6 Grad eingestellt. Zur Interpretation des Stroemungsfeldes wurden Schlierenaufnahmen der Heckumstroemung gemacht

    En el viñedo del texto.Libro y lectura en la universidad medieval.

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    La creación de las universidades en la Europa de los siglos XII y XIII acarreó algunas transformaciones en la concepción del saber y, por ende, en la función del libro y de la lectura: el llamado modelo escolástico. Éste se dejó sentir en la tipología y producción libresca. Respecto a la primera, las modalidades de mise en page, basadas en el «diálogo» texto/comentarios, y la mise en texte favorecieron la comprensión de las obras. En cuanto a lo segundo, la. pecia redujo el tiempo empleado en la copia de libros y permitió atender la mayor demanda suscitada por el público universitario.The creation of universities in the Europe of xilth and Xlllth centuries carried some transformations in the conception of knowledge and, therefore, in the function of the book and the reading: the scholastic model. This one was reflected in the typologie and books production. With respect to first, the modalities of mise en page, based on the text/commentaries «dialogue», and mise in texte favored the understanding of works. As far as the second, the pecia reduced the time used in the copy of the books and let to attend to the greater demand provoked by the university public.Publicad

    Mobile Press-Register sleeve MP0080639

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    Richard Tyson, at Friends of the Saenger Theatre [theater] benefit performance / (Saenger Theatre

    Ecology of mangroves

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    Textbook on the ecology of mangroves, detailed description of mangroves and their environment
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