{"id":7365,"date":"2021-03-18T12:37:21","date_gmt":"2021-03-18T12:37:21","guid":{"rendered":"https:\/\/www.ucf.edu.cu\/?p=7365"},"modified":"2021-03-19T12:43:29","modified_gmt":"2021-03-19T12:43:29","slug":"aprueba-cecmed-inicio-del-ensayo-clinico-fase-iii-del-candidato-vacunal-abdala-del-cigb","status":"publish","type":"post","link":"https:\/\/www.ucf.edu.cu\/?p=7365","title":{"rendered":"Aprueba CECMED inicio del ensayo cl\u00ednico fase III del candidato vacunal Abdala del CIGB"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7365\" class=\"elementor elementor-7365\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2e69c6d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2e69c6d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-99cd05d\" data-id=\"99cd05d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c652fe9 elementor-widget elementor-widget-text-editor\" data-id=\"c652fe9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La Autoridad Reguladora de Medicamentos, Equipos y Dispositivos M\u00e9dicos de la Rep\u00fablica de Cuba, CECMED <strong>aprob\u00f3, este 18 de marzo, la autorizaci\u00f3n para realizar el Ensayo Cl\u00ednico Fase III del Candidato Vacunal Abdala.<\/strong><\/p><blockquote><p>Esta aprobaci\u00f3n se fundamenta en los resultados de seguridad demostrados en los estudios Fase I y II.<\/p><\/blockquote><p>El objetivo del ensayo es evaluar la eficacia del mismo y continuar demostrando su seguridad. <strong>Este ensayo cl\u00ednico, dar\u00e1 inicio pr\u00f3ximamente en las provincias de Granma, Santiago de Cuba y Guant\u00e1namo. Incluir\u00e1 un total de 48 mil voluntarios comprendidos en las edades entre 19 y 80 a\u00f1os que den su consentimiento.<\/strong><\/p><p>El ensayo cl\u00ednico Fase III del candidato Abdala ser\u00e1 realizado en las provincias orientales del pa\u00eds y el dise\u00f1o de estudio aprobado permitir\u00e1 demostrar la eficacia del producto seg\u00fan los criterios nacionales e internacionales establecidos y recomendados por la Organizaci\u00f3n Mundial de la Salud para este tipo de vacunas.<\/p><p>El CECMED, Autoridad Reguladora de Medicamentos, Equipos y Dispositivos M\u00e9dicos\u00a0de la Rep\u00fablica de Cuba, encargada de promover y proteger la salud p\u00fablica, a trav\u00e9s de un sistema regulador capaz de garantizar el acceso oportuno al mercado de productos con calidad, seguridad, eficacia e informaci\u00f3n veraz para su uso racional, tiene entre sus funciones la aprobaci\u00f3n de los estudios cl\u00ednicos a realizar en el territorio Nacional. <strong>El centro a partir de esta aprobaci\u00f3n tiene previsto la verificaci\u00f3n del cumplimiento de Buenas Pr\u00e1cticas Cl\u00ednicas durante la ejecuci\u00f3n del ensayo.<\/strong><\/p><p><strong>(Con informaci\u00f3n de CECMED y <a href=\"https:\/\/www.biocubafarma.cu\/noticias\/noticia-post.php?id=220&amp;fbclid=IwAR19SGBmp2nS-X-LfvEeKUXkh_rcc7qNsrmyBlOHcU0jnc4-GdlYZT586ug\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">BioCubafarma<\/a>)<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>La Autoridad Reguladora de Medicamentos, Equipos y Dispositivos M\u00e9dicos de la Rep\u00fablica de Cuba, CECMED aprob\u00f3, este 18 de marzo, la autorizaci\u00f3n para realizar el Ensayo Cl\u00ednico Fase III del Candidato Vacunal<a class=\"moretag\" href=\"https:\/\/www.ucf.edu.cu\/?p=7365\">Leer m\u00e1s&#8230;<\/a><\/p>\n","protected":false},"author":6,"featured_media":7363,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-post-intra.php","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-7365","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aprueba CECMED inicio del ensayo cl\u00ednico fase III del candidato vacunal Abdala del CIGB - Universidad de Cienfuegos<\/title>\n<meta name=\"description\" content=\"Noticias del \u00e1mbito universitario de la casa de altos estudios de Cienfuegos. 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