{"id":28018,"date":"2022-06-22T08:54:06","date_gmt":"2022-06-22T06:54:06","guid":{"rendered":"https:\/\/kymos.com\/news\/bioaequivalenzstudien-in-europa\/"},"modified":"2025-12-03T19:02:41","modified_gmt":"2025-12-03T18:02:41","slug":"bioaequivalenzstudien-in-europa","status":"publish","type":"post","link":"https:\/\/kymos.com\/de\/news\/bioaequivalenzstudien-in-europa\/","title":{"rendered":"Bio\u00e4quivalenzstudien in Europa"},"content":{"rendered":"

Bio\u00e4quivalenzstudien sollen zeigen, dass zwei Arzneimittel gleichwertig und austauschbar sind. \u2013 Doch selbst wenn die Medikamente austauschbar sind, gilt dies nicht f\u00fcr die Anbieter von Bio\u00e4quivalenzstudien. <\/span><\/p>\n

Digna Tost, Abteilungsleiterin f\u00fcr Bioanalytik kleiner Molek\u00fcle bei Kymos, fasst zusammen, warum Kymos der richtige Partner f\u00fcr Bio\u00e4quivalenzprojekte ist:<\/span><\/p>\n

\n

\u201eUnsere Kunden suchen einen CRO, der hohe Qualit\u00e4tsstandards erf\u00fcllt, enge Zeitvorgaben einh\u00e4lt und dennoch wettbewerbsf\u00e4hige Preise bietet. All das finden sie bei Kymos.\u201c Bei Kymos gelten f\u00fcr unsere Bio\u00e4quivalenzprojekte h\u00f6chste Standards hinsichtlich Qualit\u00e4t und Einhaltung gesetzlicher Vorschriften.<\/strong> Alle klinischen Studien werden ausschlie\u00dflich in renommierten europ\u00e4ischen Zentren durchgef\u00fchrt. Dar\u00fcber hinaus sind wir und unsere Partner von der FDA und der EMA gepr\u00fcft und GCP\/GLP-konform. Dank jahrzehntelanger Erfahrung und guter Partnerschaften arbeiten wir zudem schnell und effizient. <\/span><\/p>\n<\/blockquote>\n

Kymos bietet einen Komplettservice f\u00fcr Bio\u00e4quivalenzstudien. Dieser umfasst das Management klinischer Studien, Bioanalytik und pharmakokinetische Bewertung, Chargenpr\u00fcfung und die EU-Freigabe von Arzneimitteln f\u00fcr die klinischen Studien. Digna Tost gibt einen \u00dcberblick \u00fcber die von Kymos angebotenen Dienstleistungen im Bereich des klinischen Studienmanagements f\u00fcr Bio\u00e4quivalenzstudien: <\/span><\/p>\n

\n

\u201e Im Bereich des klinischen Studienmanagements erhalten Sie von uns ein Komplettpaket.<\/strong> In Zusammenarbeit mit unseren klinischen Partnern unterst\u00fctzt Kymos Sie von den ersten Schritten der Bio\u00e4quivalenzstudien an: von der Erstellung der Studienprotokolle \u00fcber die Einreichung bei Ethikkommissionen und Zulassungsbeh\u00f6rden bis hin zu den entsprechenden Versicherungen. Logistisch koordinieren wir die Bereitstellung von Test- und Referenzprodukten sowie den Probenversand an das bioanalytische Labor. Als GMP-zertifiziertes Unternehmen mit Importgenehmigung f\u00fcr zugelassene Arzneimittel und Pr\u00fcfpr\u00e4parate k\u00f6nnen wir Referenz- und Testarzneimittel aus Nicht-EU-L\u00e4ndern importieren, um klinische Studien durchzuf\u00fchren. Dar\u00fcber hinaus bieten wir Ihnen auch das Monitoring klinischer Studien an.\u201c <\/span><\/p>\n<\/blockquote>\n

Kymos konzentriert sich jedoch haupts\u00e4chlich auf den bioanalytischen Bereich. In den vergangenen Jahrzehnten hat Kymos erfolgreich eine Vielzahl validierter bioanalytischer Methoden f\u00fcr verschiedene Matrices und Messbereiche entwickelt. Dank dieser Expertise k\u00f6nnen wir schnell und effizient zu minimalen Kosten f\u00fcr unsere Kunden agieren. Die Methodenliste inklusive praktischer Suchfunktion finden Sie auf unserer Serviceseite: Bio\u00e4quivalenzstudien<\/a> .<\/strong> Dar\u00fcber hinaus verf\u00fcgen wir \u00fcber zahlreiche vorentwickelte Methoden, die wir f\u00fcr unsere Kunden kostenlos validieren. F\u00fcr weitere Informationen kontaktieren Sie bitte unsere Service-Manager<\/a> . <\/span><\/p>\n

Zum Schluss verr\u00e4t Digna Tost, was Kymos in ihren Augen so besonders macht:<\/span><\/p>\n

\n

\u201eIn meiner bisherigen T\u00e4tigkeit im Bereich klinischer Studien habe ich immer wieder festgestellt, dass ein strenges klinisches Management und h\u00f6chste Qualit\u00e4t entscheidend f\u00fcr eine erfolgreiche Bio\u00e4quivalenzstudie sind. Ich freue mich sehr, dass Kymos genau dies priorisiert und dass wir so viele zufriedene Kunden haben.\u201c<\/span><\/p>\n<\/blockquote>\n<\/div>

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

Digna Tost und die Abteilung f\u00fcr Bioanalytik kleiner Molek\u00fcle<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":28020,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[254],"tags":[62],"class_list":["post-28018","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse","tag-joan"],"acf":[],"yoast_head":"\nVertrauensw\u00fcrdiger Partner f\u00fcr Bio\u00e4quivalenzstudien | Kymos-Gruppe<\/title>\n<meta name=\"description\" content=\"Bio\u00e4quivalenzstudien bei Kymos werden ausschlie\u00dflich in renommierten europ\u00e4ischen Zentren durchgef\u00fchrt. FDA\/EMA-konform. 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