{"id":22696,"date":"2019-04-28T13:38:43","date_gmt":"2019-04-28T11:38:43","guid":{"rendered":"https:\/\/kymos.com\/news\/qualitat-i-equivalencia-dels-productes-topics\/"},"modified":"2025-08-07T09:37:04","modified_gmt":"2025-08-07T07:37:04","slug":"qualitat-i-equivalencia-dels-productes-topics","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/qualitat-i-equivalencia-dels-productes-topics\/","title":{"rendered":"Qualitat i equival\u00e8ncia dels productes t\u00f2pics"},"content":{"rendered":"

El 18 d’octubre de 2018, l’EMA va publicar l’ Esborrany de la Guia sobre la Qualitat i l’Equival\u00e8ncia de Productes T\u00f2pics<\/a> . El 30 de juny de 2019 finalitzar\u00e0 el per\u00edode de consulta i s’espera que estigui en vigor a finals d’any. La guia estableix clarament que les sol\u00b7licituds reglament\u00e0ries basades en la literatura per demostrar la seguretat i l’efic\u00e0cia han d’estar avalades per dades d’equival\u00e8ncia de la formulaci\u00f3. Al mateix temps, proporciona detalls dels models in vivo<\/i> i in vitro<\/i> que poden substituir les dades cl\u00edniques i quan s\u00f3n aplicables les exempcions biol\u00f2giques. La guia cobreix espec\u00edficament: la prova d’alliberament in vitro<\/i><\/b> ( IVRT<\/b> ), els estudis de permeaci\u00f3 cut\u00e0nia in vitro<\/i><\/b> ( IVPT<\/b> ), el mostreig de l’estrat corni mitjan\u00e7ant el descal\u00e7 amb cinta adhesiva i l’assaig de vasoconstricci\u00f3 per a corticosteroides. <\/span><\/p>\n

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La IVRT<\/b> no \u00e9s un model del rendiment in vivo<\/i> de la formulaci\u00f3, per\u00f2 es pot utilitzar com a atribut de qualitat per a l’alliberament del lot i l’especificaci\u00f3 de la vida \u00fatil. La IVRT t\u00e9 com a objectiu avaluar la velocitat i l’extensi\u00f3 de l’alliberament d’una subst\u00e0ncia activa en la formulaci\u00f3 a trav\u00e9s d’una membrana, i els par\u00e0metres a provar s\u00f3n la velocitat d’alliberament del f\u00e0rmac, la quantitat acumulada i el temps de retard. <\/span><\/p>\n

La prova de prova in vitro (IVPT)<\/b> utilitza pell humana en estudis discriminatius per demostrar l’equival\u00e8ncia entre una formulaci\u00f3 de prova i un comparador conegut i pot evitar assajos cl\u00ednics amb criteri d’efic\u00e0cia. Els estudis pilot i pivotals s’han de dur a terme d’acord amb la norma ICH E8 pel que fa a l’aleatoritzaci\u00f3 i l’encegament. <\/span><\/p>\n

La prova de transmissi\u00f3 intravenosa (IVPT)<\/b> tamb\u00e9 es pot utilitzar per avaluar la manca d’absorci\u00f3 de subst\u00e0ncies medicamentoses, cosm\u00e8tics o biocides amb activitat local que no s’haurien d’absorbir per motius de seguretat.<\/span><\/p>\n

La IVRT<\/b> i la IVPT<\/b> se solen dur a terme mitjan\u00e7ant cel\u00b7les de difusi\u00f3 vertical, sent les m\u00e9s utilitzades les anomenades c\u00e8l\u00b7lules de Franz. L’\u00fas d’instruments automatitzats redueix la variabilitat, especialment quan s’utilitza pell de donants, i amb el programari adequat, proporciona resultats fiables d’acord amb la norma 21 CFR part 11. <\/span><\/p>\n

Des del punt de vista de la qualitat, l’\u00fas de proves in vitro per a productes t\u00f2pics \u00e9s una eina important per desenvolupar formulacions consistents durant el seu cicle de vida i esdevindr\u00e0 un atribut per certificar la qualitat i l’homogene\u00eftat dels lots de fabricaci\u00f3. Des de la perspectiva de l’equival\u00e8ncia, \u00e9s una porta oberta al registre de productes gen\u00e8rics a costos assequibles i tindr\u00e0 un gran impacte en els propers anys per a l’acc\u00e9s al mercat d’aquests productes. <\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

El 18 d’octubre de 2018, l’EMA va publicar l’ Esborrany […]<\/p>\n","protected":false},"author":6,"featured_media":15013,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95,97],"tags":[],"class_list":["post-22696","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","category-cmc-ca"],"acf":[],"yoast_head":"\nQualitat i equival\u00e8ncia dels productes t\u00f2pics | Kymos<\/title>\n<meta name=\"description\" content=\"M\u00e9s informaci\u00f3 sobre la Guia sobre qualitat i equival\u00e8ncia de productes t\u00f2pics i els detalls dels models in vivo i 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\/ca\/news\/qualitat-i-equivalencia-dels-productes-topics\/\" \/>\n<meta property=\"og:locale\" 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