{"id":27217,"date":"2019-04-28T13:38:43","date_gmt":"2019-04-28T11:38:43","guid":{"rendered":"https:\/\/kymos.com\/news\/qualite-et-equivalence-des-produits-topiques\/"},"modified":"2019-04-28T13:38:43","modified_gmt":"2019-04-28T11:38:43","slug":"qualite-et-equivalence-des-produits-topiques","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/qualite-et-equivalence-des-produits-topiques\/","title":{"rendered":"Qualit\u00e9 et \u00e9quivalence des produits topiques"},"content":{"rendered":"

Le 18 octobre 2018, l’EMA a publi\u00e9 le projet de ligne directrice sur la qualit\u00e9 et l’\u00e9quivalence des produits topiques<\/a> . La p\u00e9riode de consultation s’est achev\u00e9e le 30 juin 2019 et la ligne directrice devrait entrer en vigueur d’ici la fin de l’ann\u00e9e. Elle stipule clairement que les demandes d’autorisation de mise sur le march\u00e9 fond\u00e9es sur la litt\u00e9rature scientifique pour d\u00e9montrer l’innocuit\u00e9 et l’efficacit\u00e9 doivent \u00eatre \u00e9tay\u00e9es par des donn\u00e9es d’\u00e9quivalence de la formulation. Elle fournit \u00e9galement des d\u00e9tails sur les mod\u00e8les in vivo<\/i> et in vitro<\/i> pouvant se substituer aux donn\u00e9es cliniques et pr\u00e9cise les cas o\u00f9 des d\u00e9rogations aux \u00e9tudes de bio\u00e9quivalence sont applicables. La ligne directrice couvre notamment : les tests de lib\u00e9ration in vitro<\/i><\/b> ( IVRT<\/b> ), les \u00e9tudes de perm\u00e9ation cutan\u00e9e in vitro<\/i><\/b> ( IVPT<\/b> ), le pr\u00e9l\u00e8vement de la couche corn\u00e9e par adh\u00e9sif et le test de vasoconstriction pour les corticost\u00e9ro\u00efdes. <\/span><\/p>\n

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L’IVRT<\/b> ne constitue pas un mod\u00e8le de performance in vivo<\/i> de la formulation, mais peut servir de crit\u00e8re de qualit\u00e9 pour la lib\u00e9ration des lots et la sp\u00e9cification de la dur\u00e9e de conservation. L’IVRT vise \u00e0 \u00e9valuer la vitesse et l’\u00e9tendue de la lib\u00e9ration d’une substance active contenue dans la formulation \u00e0 travers une membrane. Les param\u00e8tres mesur\u00e9s sont la vitesse de lib\u00e9ration du m\u00e9dicament, la quantit\u00e9 cumul\u00e9e et le temps de latence. <\/span><\/p>\n

L\u2019IVPT<\/b> utilise la peau humaine dans des \u00e9tudes discriminatives pour d\u00e9montrer l\u2019\u00e9quivalence entre une formulation test et un comparateur reconnu, et peut permettre d\u2019\u00e9viter les essais cliniques avec crit\u00e8re d\u2019efficacit\u00e9 principal. Les \u00e9tudes pilotes et pivotales doivent \u00eatre men\u00e9es conform\u00e9ment \u00e0 la directive ICH E8 en mati\u00e8re de randomisation et d\u2019insu. <\/span><\/p>\n

L’IVPT<\/b> peut \u00e9galement \u00eatre utilis\u00e9e pour \u00e9valuer le manque d’absorption de substances m\u00e9dicamenteuses, de cosm\u00e9tiques ou de biocides \u00e0 action locale qui ne doivent pas \u00eatre absorb\u00e9s pour des raisons de s\u00e9curit\u00e9.<\/span><\/p>\n

Les techniques IVRT<\/b> et IVPT<\/b> sont g\u00e9n\u00e9ralement r\u00e9alis\u00e9es \u00e0 l’aide de cellules de diffusion verticale, les plus couramment utilis\u00e9es \u00e9tant les cellules de Franz. L’utilisation d’instruments automatis\u00e9s r\u00e9duit la variabilit\u00e9, notamment lors de l’utilisation de peau de donneur, et, avec le logiciel appropri\u00e9, garantit des r\u00e9sultats fiables conformes \u00e0 la norme 21 CFR Part 11. <\/span><\/p>\n

Du point de vue de la qualit\u00e9, le recours aux tests in vitro pour les produits topiques est un outil essentiel pour d\u00e9velopper des formulations homog\u00e8nes tout au long de leur cycle de vie et deviendra un crit\u00e8re de certification de la qualit\u00e9 et de l’homog\u00e9n\u00e9it\u00e9 des lots de fabrication. Du point de vue de l’\u00e9quivalence, il ouvre la voie \u00e0 l’enregistrement de m\u00e9dicaments g\u00e9n\u00e9riques \u00e0 un co\u00fbt abordable et aura un impact majeur sur leur acc\u00e8s au march\u00e9 dans les ann\u00e9es \u00e0 venir. <\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Le 18 octobre 2018, l’EMA a publi\u00e9 le projet de […]<\/p>\n","protected":false},"author":6,"featured_media":27220,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[257,267],"tags":[],"class_list":["post-27217","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse","category-cmc"],"acf":[],"yoast_head":"\nQualit\u00e9 et \u00e9quivalence des produits topiques | Kymos<\/title>\n<meta name=\"description\" content=\"Apprenez-en davantage sur la Ligne directrice sur la qualit\u00e9 et l\u2019\u00e9quivalence des produits topiques et sur les d\u00e9tails des mod\u00e8les in vivo et 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\/fr\/news\/qualite-et-equivalence-des-produits-topiques\/\" \/>\n<meta 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