{"id":12647,"date":"2025-02-27T17:30:00","date_gmt":"2025-02-27T16:30:00","guid":{"rendered":"https:\/\/team-mastery.eu\/?p=12647"},"modified":"2025-04-11T14:40:18","modified_gmt":"2025-04-11T12:40:18","slug":"pubblica-consultazione-sul-reflection-paper-on-the-qualification-of-non-mutagenic-impurities","status":"publish","type":"post","link":"https:\/\/team-mastery.eu\/it\/pubblica-consultazione-sul-reflection-paper-on-the-qualification-of-non-mutagenic-impurities\/","title":{"rendered":"Pubblica consultazione sul \u201cReflection paper on the qualification of non-mutagenic impurities\u201d"},"content":{"rendered":"

L’Agenzia Europea per i Medicinali (EMA) ha recentemente pubblicato un documento intitolato “Reflection paper on the qualification of non-mutagenic impurities” (EMA\/CHMP\/543397\/2024), attualmente in fase di consultazione pubblica fino al 30 aprile 2025. Questo documento affronta la valutazione della sicurezza delle impurit\u00e0 non mutagene (NMI).<\/p>\n

L’obiettivo principale di questo documento \u00e8 integrare le linee guida esistenti, come ICH Q3A e ICH Q3B, fornendo strategie alternative per qualificare nuove impurezze o livelli pi\u00f9 elevati di impurezze precedentemente qualificate a livelli inferiori. Questo \u00e8 particolarmente rilevante quando i dati derivanti dallo sviluppo (non)clinico con i lotti del principio attivo non sono considerati sufficienti per la qualificazione delle NMI.<\/p>\n

Una caratteristica distintiva di questo documento \u00e8 l’enfasi su approcci non basati su studi animali, che possono offrire informazioni pi\u00f9 specifiche sul composto rispetto agli studi su animali con lotti di principio attivo contenenti impurezze a bassi livelli. Questo approccio \u00e8 in linea con i principi delle 3R (Replacement, Reduction, Refinement), ampiamente condiviso a livello internazionale.<\/p>\n

\n
Per ulteriori dettagli e per accedere al documento completo, si prega di visitare il sito ufficiale dell’EMA<\/h6>\n

 
\nDocumento di riflessione sulla qualificazione delle impurit\u00e0 non mutagene<\/i><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

L’Agenzia Europea per i Medicinali (EMA) ha recentemente pubblicato un documento intitolato “Reflection paper on the qualification of non-mutagenic impurities”<\/p>\n","protected":false},"author":1,"featured_media":12125,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[112],"tags":[],"class_list":["post-12647","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-archivio-newsletter"],"yoast_head":"\nPubblica consultazione sul \u201cReflection paper on the qualification of non-mutagenic impurities\u201d - TEAM mastery<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/team-mastery.eu\/it\/pubblica-consultazione-sul-reflection-paper-on-the-qualification-of-non-mutagenic-impurities\/\" \/>\n<meta property=\"og:locale\" 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