{"id":23092,"date":"2018-05-25T12:14:44","date_gmt":"2018-05-25T10:14:44","guid":{"rendered":"https:\/\/kymos.com\/news\/nueva-guia-de-la-fda-sobre-la-validacion-de-metodos-bioanaliticos\/"},"modified":"2018-05-25T12:14:44","modified_gmt":"2018-05-25T10:14:44","slug":"nueva-guia-de-la-fda-sobre-la-validacion-de-metodos-bioanaliticos","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/nueva-guia-de-la-fda-sobre-la-validacion-de-metodos-bioanaliticos\/","title":{"rendered":"Nueva gu\u00eda de la FDA sobre la validaci\u00f3n de m\u00e9todos bioanal\u00edticos"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">La FDA ha publicado una Gu\u00eda para la Industria titulada \u00bb <strong>Validaci\u00f3n de M\u00e9todos Bioanal\u00edticos<\/strong> \u00ab. Esta gu\u00eda reemplaza el borrador publicado en septiembre de 2013 y refleja los avances cient\u00edficos y tecnol\u00f3gicos en la validaci\u00f3n de m\u00e9todos bioanal\u00edticos.   <\/span><\/p>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">Los m\u00e9todos bioanal\u00edticos proporcionan datos cruciales para respaldar la seguridad y eficacia de f\u00e1rmacos y productos biol\u00f3gicos. La gu\u00eda final describe los elementos del desarrollo y la validaci\u00f3n de m\u00e9todos bioanal\u00edticos para ensayos cromatogr\u00e1ficos o de uni\u00f3n de ligandos, necesarios para garantizar la calidad y fiabilidad de los datos farmacocin\u00e9ticos y de biomarcadores que genera. Adem\u00e1s, describe c\u00f3mo evaluar nuevas tecnolog\u00edas anal\u00edticas y c\u00f3mo evaluar la validaci\u00f3n de muestras de sangre seca y kits comerciales reutilizados para el desarrollo de f\u00e1rmacos. Las tablas de referencia incluidas en la gu\u00eda pueden ayudar a los patrocinadores con la validaci\u00f3n de m\u00e9todos y la documentaci\u00f3n de informes de estudios para respaldar la solicitud de medicamentos ante la FDA.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">La gu\u00eda final se puede encontrar aqu\u00ed: <strong><a href=\"https:\/\/kymos.com\/es\/servicios\/analisis-y-control-de-calidad-de-cmc\/desarrollo-y-validacion-de-metodos\/\" data-wpel-link=\"internal\">Validaci\u00f3n de m\u00e9todos bioanal\u00edticos<\/a> .<\/strong><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La FDA ha publicado una Gu\u00eda para la Industria titulada  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":21700,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[],"class_list":["post-23092","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisis"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nueva gu\u00eda de la FDA sobre la validaci\u00f3n de m\u00e9todos bioanal\u00edticos | Kymos<\/title>\n<meta name=\"description\" content=\"Obtenga m\u00e1s informaci\u00f3n sobre la nueva gu\u00eda para la industria titulada &quot;Validaci\u00f3n de m\u00e9todos bioanal\u00edticos&quot; emitida por la FDA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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