{"id":28006,"date":"2022-06-22T08:54:06","date_gmt":"2022-06-22T06:54:06","guid":{"rendered":"https:\/\/kymos.com\/news\/studi-di-bioequivalenza-in-europa\/"},"modified":"2025-12-03T19:02:41","modified_gmt":"2025-12-03T18:02:41","slug":"studi-di-bioequivalenza-in-europa","status":"publish","type":"post","link":"https:\/\/kymos.com\/it\/news\/studi-di-bioequivalenza-in-europa\/","title":{"rendered":"Studi di bioequivalenza in Europa"},"content":{"rendered":"

Gli studi di bioequivalenza sono progettati per dimostrare che due farmaci sono equivalenti e sostituibili. – Tuttavia, anche se i medicinali sono sostituibili, chi fornisce gli studi di bioequivalenza non lo \u00e8. <\/span><\/p>\n

Digna Tost, responsabile del dipartimento di bioanalisi delle piccole molecole presso Kymos, riassume perch\u00e9 Kymos \u00e8 il partner giusto per i progetti di bioequivalenza:<\/span><\/p>\n

\n

“I nostri clienti cercano una CRO che abbia elevati standard qualitativi, rispetti tempi stretti e offra prezzi competitivi. Tutto questo lo trovano con Kymos. In Kymos adottiamo gli standard pi\u00f9 elevati per la qualit\u00e0 e la conformit\u00e0 normativa dei nostri progetti di bioequivalenza.<\/strong> Tutti gli studi clinici vengono condotti esclusivamente in rinomati centri europei. Inoltre, noi e i nostri partner siamo ispezionati da FDA ed EMA e conformi alle norme GCP\/GLP. Inoltre, grazie a decenni di esperienza e a solide partnership, lavoriamo in modo rapido ed efficiente. <\/span><\/p>\n<\/blockquote>\n

Kymos offre un servizio completo per gli studi di bioequivalenza. Dalla gestione degli studi clinici, alla bioanalisi e alla valutazione farmacocinetica, fino ai test sui lotti e all’autorizzazione all’immissione in commercio nell’Unione Europea dei farmaci da utilizzare negli studi clinici. Digna Tost offre una panoramica dei servizi di gestione degli studi clinici offerti da Kymos per gli studi di bioequivalenza: <\/span><\/p>\n

\n

” Nella gestione degli studi clinici, offriamo un pacchetto “tutto compreso”.<\/strong> In collaborazione con i nostri partner clinici, Kymos fornisce supporto fin dalle prime fasi degli studi di bioequivalenza: dalla stesura dei protocolli clinici alla gestione delle richieste ai comitati etici e alle autorit\u00e0 regolatorie, nonch\u00e9 alle relative assicurazioni. Dal punto di vista logistico, coordiniamo la fornitura di prodotti di prova e di riferimento, nonch\u00e9 la spedizione dei campioni al centro di bioanalisi. Siamo un’azienda certificata GMP con un’autorizzazione all’importazione per medicinali commercializzati e IMP che ci consente l’importazione di prodotti di riferimento e di prova da paesi extra-UE al fine di condurre studi clinici. Inoltre, possiamo offrire il monitoraggio degli studi clinici.” <\/span><\/p>\n<\/blockquote>\n

Tuttavia, l’attenzione principale di Kymos \u00e8 naturalmente rivolta al campo bioanalitico. Negli ultimi decenni, Kymos \u00e8 riuscita a sviluppare un lungo elenco di metodi bioanalitici validati in diverse matrici e con diversi intervalli di misura. Grazie a tale competenza, possiamo agire in modo rapido ed efficiente con costi minimi per i nostri clienti. L’elenco dei metodi, inclusa una comoda funzione di ricerca, \u00e8 disponibile sulla nostra pagina dedicata ai servizi: Studi di bioequivalenza<\/g> .<\/g> Inoltre, disponiamo di un numero significativo di metodi pre-sviluppati che convalidiamo gratuitamente per i nostri clienti. Per ulteriori informazioni, contattate i nostri responsabili dei servizi<\/a> . <\/span><\/p>\n

Infine, Digna Tost rivela cosa rende Kymos speciale ai suoi occhi:<\/span><\/p>\n

\n

“Nella mia passata esperienza negli studi clinici, ho sempre constatato che una gestione clinica rigorosa e la massima qualit\u00e0 sono fondamentali per il successo di uno studio di bioequivalenza. Sono molto felice che Kymos dia esattamente questa priorit\u00e0 e che abbiamo cos\u00ec tanti clienti soddisfatti.”<\/span><\/p>\n<\/blockquote>\n<\/div>

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

Digna Tost e il Dipartimento di Bioanalisi delle Piccole Molecole<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":28008,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[253],"tags":[62],"class_list":["post-28006","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi","tag-joan"],"acf":[],"yoast_head":"\nPartner di fiducia per studi di bioequivalenza | Kymos Group<\/title>\n<meta name=\"description\" content=\"Gli studi di bioequivalenza presso Kymos vengono eseguiti esclusivamente in rinomati centri europei. Conformi alle normative FDA\/EMA. 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