{"id":27128,"date":"2018-05-25T12:14:44","date_gmt":"2018-05-25T10:14:44","guid":{"rendered":"https:\/\/kymos.com\/news\/nuove-linee-guida-della-fda-sulla-convalida-del-metodo-bioanalitico\/"},"modified":"2018-05-25T12:14:44","modified_gmt":"2018-05-25T10:14:44","slug":"nuove-linee-guida-della-fda-sulla-convalida-del-metodo-bioanalitico","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/nuove-linee-guida-della-fda-sulla-convalida-del-metodo-bioanalitico\/","title":{"rendered":"Nuove linee guida della FDA sulla convalida del metodo bioanalitico"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">La FDA ha pubblicato una guida per l&#8217;industria intitolata &#8221; <strong>Validazione dei metodi bioanalitici<\/strong> &#8220;. Questa guida sostituisce la bozza pubblicata nel settembre 2013 e riflette i progressi della scienza e della tecnologia nella convalida dei metodi bioanalitici.   <\/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;\">I metodi bioanalitici forniscono dati essenziali a supporto della sicurezza e dell&#8217;efficacia di farmaci e prodotti biologici. La guida definitiva descrive gli elementi dello sviluppo e della convalida dei metodi bioanalitici per saggi cromatografici o di legame dei ligandi, necessari per garantire la qualit\u00e0 e l&#8217;affidabilit\u00e0 dei dati farmacocinetici e dei biomarcatori generati, e descrive come valutare nuove tecnologie analitiche e come valutare la convalida del campionamento di gocce di sangue essiccato e dei kit commerciali riutilizzati per lo sviluppo di farmaci. Le tabelle di riferimento incluse nella guida possono aiutare gli sponsor nella convalida dei metodi e nella documentazione dei report di studio a supporto della domanda di autorizzazione all&#8217;immissione in commercio dei farmaci da parte della FDA.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Le linee guida definitive sono disponibili qui: <strong><a href=\"https:\/\/kymos.com\/it\/servizi\/analisi-cmc-e-controllo-qualita\/sviluppo-e-convalida-del-metodo\/\" data-wpel-link=\"internal\">Validazione del metodo bioanalitico<\/a> .<\/strong><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La FDA ha pubblicato una guida per l&#8217;industria intitolata &#8221;  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":27130,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[253],"tags":[],"class_list":["post-27128","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 v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nuove linee guida della FDA sulla convalida del metodo bioanalitico | Kymos<\/title>\n<meta name=\"description\" content=\"Scopri di pi\u00f9 sulla nuova guida per l&#039;industria intitolata &quot;Bioanalytical Method Validation&quot; emessa dalla 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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