{"id":27206,"date":"2019-04-28T13:38:43","date_gmt":"2019-04-28T11:38:43","guid":{"rendered":"https:\/\/kymos.com\/news\/qualita-ed-equivalenza-dei-prodotti-topici\/"},"modified":"2019-04-28T13:38:43","modified_gmt":"2019-04-28T11:38:43","slug":"qualita-ed-equivalenza-dei-prodotti-topici","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/qualita-ed-equivalenza-dei-prodotti-topici\/","title":{"rendered":"Qualit\u00e0 ed equivalenza dei prodotti topici"},"content":{"rendered":"

Il 18 ottobre 2018 l’EMA ha pubblicato la bozza delle linee guida sulla qualit\u00e0 e l’equivalenza dei prodotti topici<\/a> . Il 30 giugno 2019 si concluder\u00e0 il periodo di consultazione e si prevede che entreranno in vigore entro la fine dell’anno. Le linee guida stabiliscono chiaramente che le domande di autorizzazione all’immissione in commercio basate sulla letteratura per dimostrare la sicurezza e l’efficacia devono essere supportate da dati di equivalenza della formulazione. Allo stesso tempo, forniscono dettagli sui modelli in vivo<\/i> e in vitro<\/i> che possono sostituire i dati clinici e quando sono applicabili i biowaiver. Le linee guida riguardano specificamente: test di rilascio in vitro<\/i><\/b> ( IVRT<\/b> ), studi di permeazione cutanea in vitro<\/i><\/b> ( IVPT<\/b> ), campionamento dello strato corneo mediante stripping con nastro adesivo e test di vasocostrizione per i corticosteroidi. <\/span><\/p>\n

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L’IVRT<\/b> non \u00e8 un modello di prestazione in vivo<\/i> della formulazione, ma pu\u00f2 essere utilizzato come attributo di qualit\u00e0 per il rilascio del lotto e le specifiche di shelf-life. L’IVRT \u00e8 finalizzato a valutare la velocit\u00e0 e l’estensione del rilascio di un principio attivo nella formulazione attraverso una membrana e i parametri da testare sono la velocit\u00e0 di rilascio del farmaco, la quantit\u00e0 cumulativa e il tempo di latenza. <\/span><\/p>\n

L’IVPT<\/b> utilizza la pelle umana in studi discriminativi per dimostrare l’equivalenza tra una formulazione sperimentale e un comparatore noto, evitando cos\u00ec studi clinici con endpoint di efficacia. Gli studi pilota e pivotal devono essere condotti in linea con l’ICH E8 in termini di randomizzazione e cecit\u00e0. <\/span><\/p>\n

L’IVPT<\/b> pu\u00f2 essere utilizzato anche per valutare la mancanza di assorbimento di sostanze farmacologiche, cosmetici o biocidi con attivit\u00e0 locale che non dovrebbero essere assorbiti per motivi di sicurezza.<\/span><\/p>\n

IVRT<\/b> e IVPT<\/b> vengono solitamente eseguite utilizzando celle a diffusione verticale, tra cui le cosiddette celle di Franz, le pi\u00f9 comunemente utilizzate. L’uso di strumenti automatizzati riduce la variabilit\u00e0, soprattutto quando si utilizza la pelle di donatori, e con il software appropriato, fornisce risultati affidabili conformi alla norma 21 CFR parte 11. <\/span><\/p>\n

Dal punto di vista della qualit\u00e0, l’utilizzo di test in vitro per i prodotti topici \u00e8 uno strumento importante per sviluppare formulazioni coerenti durante il loro ciclo di vita e diventer\u00e0 un attributo per certificare la qualit\u00e0 e l’omogeneit\u00e0 dei lotti di produzione. Dal punto di vista dell’equivalenza, rappresenta una porta aperta alla registrazione di prodotti generici a costi accessibili e avr\u00e0 un impatto significativo negli anni a venire sull’accesso al mercato di questi prodotti. <\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Il 18 ottobre 2018 l’EMA ha pubblicato la bozza delle […]<\/p>\n","protected":false},"author":6,"featured_media":27208,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[253,264],"tags":[],"class_list":["post-27206","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","category-cmc"],"acf":[],"yoast_head":"\nQualit\u00e0 ed equivalenza dei prodotti topici | Kymos<\/title>\n<meta name=\"description\" content=\"Scopri di pi\u00f9 sulle linee guida sulla qualit\u00e0 e l'equivalenza dei prodotti topici e sui dettagli dei modelli in vivo e in vitro.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/it\/news\/qualita-ed-equivalenza-dei-prodotti-topici\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta 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