{"id":27060,"date":"2018-02-13T12:04:59","date_gmt":"2018-02-13T11:04:59","guid":{"rendered":"https:\/\/kymos.com\/news\/metodi-bioanalitici-adatti-allo-scopo-validazione-scientifica\/"},"modified":"2018-02-13T12:04:59","modified_gmt":"2018-02-13T11:04:59","slug":"metodi-bioanalitici-adatti-allo-scopo-validazione-scientifica","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/metodi-bioanalitici-adatti-allo-scopo-validazione-scientifica\/","title":{"rendered":"Metodi bioanalitici adatti allo scopo: validazione scientifica"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">Negli ultimi 25 anni, i criteri richiesti per i metodi bioanalitici si sono evoluti in modo significativo. L&#8217;armonizzazione dei requisiti dei metodi bioanalitici \u00e8 iniziata nel 1990 durante i meeting AAPS e FDA di Crystal City. Nel 2000, il meeting di Crystal City II ha gettato le basi per le linee guida FDA del 2001 sulla convalida dei metodi bioanalitici. Nel 2011, l&#8217;EMA ha pubblicato le proprie linee guida sulla convalida dei metodi bioanalitici, che forniscono raccomandazioni per la convalida dei metodi bioanalitici applicati alla misurazione delle concentrazioni di farmaci in matrici biologiche ottenute in studi tossicocinetici su animali e in tutte le fasi degli studi clinici. Queste linee guida hanno armonizzato la convalida dei metodi bioanalitici negli studi preclinici, clinici e di bioequivalenza. Tuttavia, i requisiti per soddisfare le linee guida sono costosi e richiedono molto tempo e non soddisfano le esigenze del settore quando i test bioanalitici sono progettati per prendere decisioni di scarsa rilevanza nelle fasi iniziali dello sviluppo del farmaco e quando utilizzati in matrici speciali.     <\/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<div>\n<p><span style=\"font-size: 14pt;\">Dal 2006, il concetto di approccio <strong>&#8220;fit-to-purpose&#8221;<\/strong> \u00e8 entrato a far parte del dibattito bioanalitico quando, a Crystal City III, \u00e8 stato proposto un approccio a pi\u00f9 livelli per la convalida dei metodi bioanalitici. Il concetto di approccio a pi\u00f9 livelli prevede diversi livelli di <strong>convalida scientifica<\/strong> come alternativa all&#8217;applicazione dei principi di convalida normativa consolidati. Questo approccio pi\u00f9 flessibile consente di suddividere le prestazioni e la valutazione del metodo in quattro livelli decrescenti, a seconda dello scopo finale dei dati bioanalitici: 1) Validazione, destinata agli studi normativi, 2) Qualificazione, 3) Ricerca e 4) Screening.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Pi\u00f9 recentemente, i rappresentanti dell&#8217;industria (all&#8217;interno dell&#8217;European Bioanalytical Forum) hanno proposto di ridenominare questo approccio a pi\u00f9 livelli in <strong>&#8220;validazione scientifica&#8221;<\/strong> , con l&#8217;obiettivo di enfatizzare la qualit\u00e0 dei dati generati da questi flussi di lavoro di convalida alternativi, pur aderendo all&#8217;obiettivo di ottimizzare la scienza e le risorse. Hanno definito un&#8217;applicazione pratica di questo concetto in cinque aree chiave del supporto bioanalitico: 1) Quantificazione dei metaboliti nelle fasi iniziali di sviluppo (come raccomandato in Crystal City III), 2) Analisi delle urine in tutte le fasi di sviluppo, 3) Analisi dei tessuti (omogenati) anche in tutte le fasi di sviluppo, 4) Studi clinici nelle fasi iniziali di sviluppo del farmaco e 5) Studi preclinici non fondamentali in GLP.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Il piano di qualificazione per la validazione scientifica <strong>idonea allo scopo<\/strong> deve essere adeguatamente giustificato per soddisfare gli obiettivi dello studio con un livello adeguato di affidabilit\u00e0 e qualit\u00e0 dei dati.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Negli ultimi 25 anni, i criteri richiesti per i metodi  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":27063,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[253],"tags":[],"class_list":["post-27060","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>Validazione di metodi bioanalitici adatti allo scopo | Kymos Group<\/title>\n<meta name=\"description\" content=\"Scopri di pi\u00f9 sulla validazione scientifica dei metodi bioanalitici adatti allo scopo con il nuovo post del blog di Kymos.\" \/>\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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