{"id":28027,"date":"2022-06-22T08:54:06","date_gmt":"2022-06-22T06:54:06","guid":{"rendered":"https:\/\/kymos.com\/news\/etudes-de-bioequivalence-en-europe\/"},"modified":"2025-12-03T19:02:41","modified_gmt":"2025-12-03T18:02:41","slug":"etudes-de-bioequivalence-en-europe","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/etudes-de-bioequivalence-en-europe\/","title":{"rendered":"\u00c9tudes de bio\u00e9quivalence en Europe"},"content":{"rendered":"

Les \u00e9tudes de bio\u00e9quivalence visent \u00e0 d\u00e9montrer que deux m\u00e9dicaments sont \u00e9quivalents et substituables. \u2013 Mais m\u00eame si les m\u00e9dicaments sont rempla\u00e7ables, les prestataires de ces \u00e9tudes ne le sont pas. <\/span><\/p>\n

Digna Tost, responsable du d\u00e9partement de bioanalyse des petites mol\u00e9cules chez Kymos, explique pourquoi Kymos est le partenaire id\u00e9al pour les projets de bio\u00e9quivalence :<\/span><\/p>\n

\n

\u00ab Nos clients recherchent un CRO qui respecte des normes de qualit\u00e9 \u00e9lev\u00e9es, des d\u00e9lais serr\u00e9s et qui propose des prix comp\u00e9titifs. Ils trouvent tout cela chez Kymos. \u00bb Chez Kymos, nous appliquons les normes les plus strictes en mati\u00e8re de qualit\u00e9 et de conformit\u00e9 r\u00e9glementaire pour nos projets de bio\u00e9quivalence.<\/strong> Toutes les \u00e9tudes cliniques sont men\u00e9es exclusivement dans des centres europ\u00e9ens de renom. De plus, nous et nos partenaires sommes inspect\u00e9s par la FDA et l’EMA et respectons les BPC\/BPL. Enfin, gr\u00e2ce \u00e0 des d\u00e9cennies d’exp\u00e9rience et \u00e0 d’excellents partenariats, nous travaillons \u00e9galement avec rapidit\u00e9 et efficacit\u00e9. <\/span><\/p>\n<\/blockquote>\n

Kymos propose un service complet pour les \u00e9tudes de bio\u00e9quivalence. De la gestion des essais cliniques \u00e0 la bioanalyse et \u00e0 l’\u00e9valuation pharmacocin\u00e9tique, en passant par les tests par lots et l’autorisation de mise sur le march\u00e9 des m\u00e9dicaments destin\u00e9s aux essais cliniques au sein de l’UE, Kymos prend en charge l’ensemble des aspects. Digna Tost pr\u00e9sente un aper\u00e7u des services de gestion des essais cliniques propos\u00e9s par Kymos pour les \u00e9tudes de bio\u00e9quivalence : <\/span><\/p>\n

\n

En mati\u00e8re de gestion d’essais cliniques, nous vous proposons une offre compl\u00e8te.<\/strong> En collaboration avec nos partenaires cliniques, Kymos vous accompagne d\u00e8s les premi\u00e8res \u00e9tapes des \u00e9tudes de bio\u00e9quivalence : r\u00e9daction des protocoles cliniques, soumission aux comit\u00e9s d’\u00e9thique et aux autorit\u00e9s r\u00e9glementaires, et gestion des assurances. Sur le plan logistique, nous coordonnons la fourniture des produits de test et de r\u00e9f\u00e9rence, ainsi que l’exp\u00e9dition des \u00e9chantillons vers le laboratoire de bioanalyse. Certifi\u00e9s BPF et disposant d’une autorisation d’importation de m\u00e9dicaments commercialis\u00e9s et de m\u00e9dicaments exp\u00e9rimentaux, nous sommes habilit\u00e9s \u00e0 importer des m\u00e9dicaments de r\u00e9f\u00e9rence et de test depuis des pays hors UE pour la r\u00e9alisation d’essais cliniques. Nous proposons \u00e9galement un service de monitoring des essais cliniques. <\/span><\/p>\n<\/blockquote>\n

Toutefois, l’activit\u00e9 principale de Kymos se concentre naturellement sur la bioanalyse. Au cours des derni\u00e8res d\u00e9cennies, Kymos a d\u00e9velopp\u00e9 avec succ\u00e8s un vaste catalogue de m\u00e9thodes bioanalytiques valid\u00e9es, applicables \u00e0 diff\u00e9rentes matrices et couvrant diverses gammes de param\u00e8tres. Gr\u00e2ce \u00e0 cette expertise, nous pouvons intervenir rapidement et efficacement, \u00e0 moindre co\u00fbt pour nos clients. La liste des m\u00e9thodes, accompagn\u00e9e d’une fonction de recherche pratique, est disponible sur notre page d\u00e9di\u00e9e aux \u00e9tudes de bio\u00e9quivalence<\/a> .<\/strong> De plus, nous proposons un grand nombre de m\u00e9thodes pr\u00e9-d\u00e9velopp\u00e9es que nous validons gratuitement pour nos clients. Pour plus d’informations, veuillez contacter nos responsables de service<\/a> . <\/span><\/p>\n

Enfin, Digna Tost r\u00e9v\u00e8le ce qui rend Kymos si sp\u00e9cial \u00e0 ses yeux :<\/span><\/p>\n

\n

\u00ab D\u2019apr\u00e8s mon exp\u00e9rience en mati\u00e8re d\u2019essais cliniques, j\u2019ai toujours constat\u00e9 qu\u2019une gestion clinique rigoureuse et une qualit\u00e9 irr\u00e9prochable sont essentielles \u00e0 la r\u00e9ussite d\u2019une \u00e9tude de bio\u00e9quivalence. Je suis ravi que Kymos accorde pr\u00e9cis\u00e9ment cette priorit\u00e9 et que nous comptions autant de clients satisfaits. \u00bb<\/span><\/p>\n<\/blockquote>\n<\/div>

\"bioanalysis<\/span><\/div>

Digna Tost et le D\u00e9partement de bioanalyse des petites mol\u00e9cules<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":28028,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[257],"tags":[62],"class_list":["post-28027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse","tag-joan"],"acf":[],"yoast_head":"\nPartenaire de confiance pour les \u00e9tudes de bio\u00e9quivalence | Groupe Kymos<\/title>\n<meta name=\"description\" content=\"Les \u00e9tudes de bio\u00e9quivalence r\u00e9alis\u00e9es chez Kymos sont exclusivement men\u00e9es dans des centres europ\u00e9ens de renom. Conformes aux normes FDA\/EMA. 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