{"id":16961,"date":"2026-10-08T16:57:04","date_gmt":"2026-10-08T14:57:04","guid":{"rendered":"https:\/\/team-mastery.eu\/?p=16961"},"modified":"2026-10-08T17:03:56","modified_gmt":"2026-10-08T15:03:56","slug":"la-fda-apre-alla-possibilita-di-applicare-lapproccio-less-than-lifetime-ltl-alle-nitrosammine","status":"publish","type":"post","link":"https:\/\/team-mastery.eu\/it\/la-fda-apre-alla-possibilita-di-applicare-lapproccio-less-than-lifetime-ltl-alle-nitrosammine\/","title":{"rendered":"La FDA apre alla possibilit\u00e0 di applicare l\u2019approccio less-than-lifetime (LTL) alle nitrosammine"},"content":{"rendered":"<p>Il 24 settembre 2026, il CDER ha annunciato che l\u2019approccio LTL descritto nella linea guida ICH M7(R2) pu\u00f2 ora essere applicato ai limiti di acceptable intake (AI) per le impurezze di nitrosammine. Fino ad oggi, il CDER non aveva accettato questo approccio.<\/p>\n<p><strong>Cosa significa in pratica:<\/strong><\/p>\n<ul>\n<li>I medicinali destinati a trattamenti di durata pi\u00f9 breve, come definita nelle informazioni approvate del prodotto, possono giustificare limiti di AI pi\u00f9 elevati (<strong>fino a 80 volte<\/strong> per trattamenti di durata pari o inferiore a 1 mese).<\/li>\n<li>I richiedenti con domande attualmente in valutazione presso la FDA dovrebbero informare il CDER qualora intendano proporre un limite di AI adeguato secondo l\u2019approccio LTL e modificare di conseguenza la propria domanda.<\/li>\n<\/ul>\n<p>Si tratta di un\u2019opportunit\u00e0 significativa per le terapie a breve termine e intermittenti, a condizione che sia supportata da una solida giustificazione scientifica.<\/p>\n<p>In TEAM mastery supportiamo le aziende nella valutazione del rischio legato alle nitrosammine e nella determinazione dei limiti di AI. Contattaci per scoprire se i tuoi prodotti possono beneficiare di questo approccio.<\/p>\n<p><a class=\"ts-vc_general ts-vc_btn3 ts-vc_btn3-size-xs ts-vc_btn3-shape-rounded ts-vc_btn3-style-outline ts-vc_btn3-weight-no ts-vc_btn3-icon-right ts-vc_btn3-color-skincolor team2\" title=\"\" href=\"https:\/\/www.fda.gov\/media\/195007\/download?attachment\" target=\"_blank\" rel=\"noopener\">Leggi il documento completo della FDA<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Il 24 settembre 2026, il CDER ha annunciato che l\u2019approccio LTL descritto nella linea guida ICH M7(R2) pu\u00f2 ora essere applicato ai limiti di acceptable intake (AI) per le impurezze di nitrosammine. Fino ad oggi, il CDER non aveva accettato questo approccio.<\/p>\n","protected":false},"author":1,"featured_media":16954,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[120],"tags":[],"class_list":["post-16961","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletter-it"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA: applicare l\u2019approccio LTL alle nitrosammine<\/title>\n<meta name=\"description\" content=\"Il CDER ha annunciato che l\u2019approccio LTL descritto nella linea guida ICH M7(R2) pu\u00f2 ora essere applicato ai limiti di acceptable intake (AI)\" \/>\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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