{"id":91817,"date":"2018-03-11T10:10:39","date_gmt":"2018-03-11T10:10:39","guid":{"rendered":"https:\/\/www.deberes.net\/tesis\/sin-categoria\/analisis-de-las-bases-regulatorias-de-los-medicamentos-biotecnologicos-biosimilares\/"},"modified":"2018-03-11T10:10:39","modified_gmt":"2018-03-11T10:10:39","slug":"analisis-de-las-bases-regulatorias-de-los-medicamentos-biotecnologicos-biosimilares","status":"publish","type":"post","link":"https:\/\/www.deberes.net\/tesis\/evaluacion-de-farmacos\/analisis-de-las-bases-regulatorias-de-los-medicamentos-biotecnologicos-biosimilares\/","title":{"rendered":"Analisis de las bases regulatorias de los medicamentos biotecnologicos: biosimilares"},"content":{"rendered":"<h2>Tesis doctoral de <strong> Leire Zu\u00f1iga Hernando <\/strong><\/h2>\n<p>La tesis doctoral aborda los aspectos legislativos implicados en la aprobaci\u00f3n y puesta en el mercado de las especialidades biotecnol\u00f3gicas en la uni\u00f3n europea, centr\u00e1ndose en los medicamentos biosimilares. Se han analizado los requisitos regulatorios necesarios, tanto desde el punto de vista de su desarrollo y producci\u00f3n, como desde el punto de vista post-autorizaci\u00f3n. Asimismo, se han clarificado los datos requeridos para completar el expediente de registro que debe presentarse a las autoridades sanitarias, en este caso a la agencia europea del medicamento (emea), para este tipo de medicamentos.  por otra parte, se ha realizado una valoraci\u00f3n de la seguridad de los medicamentos biosimilares, considerando los requisitos de gesti\u00f3n de riesgos y planes de farmacovigilancia que se deben implementar para  su comercializaci\u00f3n.  por \u00faltimo, se ha analizado la capacidad de sustituci\u00f3n de los medicamentos biosimilares por sus correspondientes medicamentos innovadores.<\/p>\n<p>&nbsp;<\/p>\n<h3>Datos acad\u00e9micos de la tesis doctoral \u00ab<strong>Analisis de las bases regulatorias de los medicamentos biotecnologicos: biosimilares<\/strong>\u00ab<\/h3>\n<ul>\n<li><strong>T\u00edtulo de la tesis:<\/strong>\u00a0 Analisis de las bases regulatorias de los medicamentos biotecnologicos: biosimilares <\/li>\n<li><strong>Autor:<\/strong>\u00a0 Leire Zu\u00f1iga Hernando <\/li>\n<li><strong>Universidad:<\/strong>\u00a0 Pa\u00eds vasco\/euskal herriko unibertsitatea<\/li>\n<li><strong>Fecha de lectura de la tesis:<\/strong>\u00a0 23\/02\/2009<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Direcci\u00f3n y tribunal<\/h3>\n<ul>\n<li><strong>Director de la tesis<\/strong>\n<ul>\n<li>M\u00aa Bego\u00f1a Calvo Hernaez<\/li>\n<\/ul>\n<\/li>\n<li><strong>Tribunal<\/strong>\n<ul>\n<li>Presidente del tribunal: alfonso Jes\u00fas Dominguez gil hurle <\/li>\n<li>sol Ruiz antunez (vocal)<\/li>\n<li>joaquin Giraldez deiro (vocal)<\/li>\n<li>M\u00aaangeles Solinis aspiazu (vocal)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tesis doctoral de Leire Zu\u00f1iga Hernando La tesis doctoral aborda los aspectos legislativos implicados en la aprobaci\u00f3n y puesta en [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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