{"id":22697,"date":"2018-05-25T12:14:44","date_gmt":"2018-05-25T10:14:44","guid":{"rendered":"https:\/\/kymos.com\/news\/nova-guia-de-la-fda-sobre-la-validacio-de-metodes-bioanalitics\/"},"modified":"2018-05-25T12:14:44","modified_gmt":"2018-05-25T10:14:44","slug":"nova-guia-de-la-fda-sobre-la-validacio-de-metodes-bioanalitics","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/nova-guia-de-la-fda-sobre-la-validacio-de-metodes-bioanalitics\/","title":{"rendered":"Nova guia de la FDA sobre la validaci\u00f3 de m\u00e8todes bioanal\u00edtics"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">La FDA ha publicat una guia per a la ind\u00fastria titulada &#8221; <strong>Validaci\u00f3 de m\u00e8todes bioanal\u00edtics<\/strong> &#8220;. Aquesta guia substitueix l&#8217;esborrany de la guia que es va publicar el setembre de 2013 i reflecteix els aven\u00e7os en la ci\u00e8ncia i la tecnologia que validen els m\u00e8todes bioanal\u00edtics.   <\/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;\">Els m\u00e8todes bioanal\u00edtics proporcionen dades cr\u00edtiques per donar suport a la seguretat i l&#8217;efic\u00e0cia dels f\u00e0rmacs i productes biol\u00f2gics. La guia final descriu els elements del desenvolupament i la validaci\u00f3 de m\u00e8todes bioanal\u00edtics per a assaigs cromatogr\u00e0fics o d&#8217;uni\u00f3 a lligands que s\u00f3n necessaris per garantir la qualitat i la fiabilitat de les dades farmacocin\u00e8tiques i de biomarcadors que genera i descriu com avaluar noves tecnologies anal\u00edtiques i com avaluar la validaci\u00f3 del mostreig de taques de sang seca i dels kits comercials que es reutilitzen per al desenvolupament de f\u00e0rmacs. Les taules de refer\u00e8ncia incloses a la guia poden ajudar els patrocinadors amb la validaci\u00f3 de m\u00e8todes i la documentaci\u00f3 de l&#8217;informe d&#8217;estudi per donar suport a la sol\u00b7licitud de f\u00e0rmacs de la FDA.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">La guia final es pot trobar aqu\u00ed: <strong><a href=\"https:\/\/kymos.com\/ca\/serveis\/cmc-analisi-i-control-de-qualitat\/desenvolupament-i-validacio-de-metodes\/\" data-wpel-link=\"internal\">Validaci\u00f3 de m\u00e8todes bioanal\u00edtics<\/a> .<\/strong><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La FDA ha publicat una guia per a la ind\u00fastria  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":15002,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95],"tags":[],"class_list":["post-22697","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nova guia de la FDA sobre la validaci\u00f3 de m\u00e8todes bioanal\u00edtics | Kymos<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre la nova guia per a la ind\u00fastria titulada &quot;Validaci\u00f3 del m\u00e8tode bioanal\u00edtic&quot; publicada per 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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