{"id":27132,"date":"2018-05-25T12:14:44","date_gmt":"2018-05-25T10:14:44","guid":{"rendered":"https:\/\/kymos.com\/news\/neue-fda-leitlinien-zur-validierung-bioanalytischer-methoden\/"},"modified":"2018-05-25T12:14:44","modified_gmt":"2018-05-25T10:14:44","slug":"neue-fda-leitlinien-zur-validierung-bioanalytischer-methoden","status":"publish","type":"post","link":"https:\/\/kymos.com\/de\/news\/neue-fda-leitlinien-zur-validierung-bioanalytischer-methoden\/","title":{"rendered":"Neue FDA-Leitlinien zur Validierung bioanalytischer Methoden"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">Die FDA hat eine Leitlinie f\u00fcr die Industrie mit dem Titel \u201e <strong>Validierung bioanalytischer Methoden<\/strong> \u201c herausgegeben. Diese Leitlinie ersetzt den im September 2013 ver\u00f6ffentlichten Entwurf und tr\u00e4gt den Fortschritten in Wissenschaft und Technologie bei der Validierung bioanalytischer Methoden Rechnung.   <\/span><\/p>\n<div class=\"blog-content\">\n<div class=\"field field-name-body field-type-text-with-summary field-label-hidden\">\n<div class=\"field-items\">\n<div class=\"field-item even\">\n<p><span style=\"font-size: 14pt;\">Bioanalytische Methoden liefern entscheidende Daten zur Unterst\u00fctzung der Sicherheit und Wirksamkeit von Arzneimitteln und Biologika. Die finale Leitlinie beschreibt die Elemente der Entwicklung und Validierung bioanalytischer Methoden f\u00fcr chromatographische oder Ligandenbindungsassays, die erforderlich sind, um die Qualit\u00e4t und Zuverl\u00e4ssigkeit der generierten PK- und Biomarkerdaten zu gew\u00e4hrleisten. Sie beschreibt au\u00dferdem, wie neue Analysetechnologien bewertet und die Validierung von Trockenblutproben und kommerziellen Kits, die f\u00fcr die Arzneimittelentwicklung umfunktioniert werden, beurteilt werden kann. Die in der Leitlinie enthaltenen Referenztabellen k\u00f6nnen Sponsoren bei der Methodenvalidierung und der Dokumentation von Studienberichten zur Unterst\u00fctzung der FDA-Zulassungsantr\u00e4ge helfen.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Die abschlie\u00dfenden Richtlinien finden Sie hier: <strong><a href=\"https:\/\/kymos.com\/de\/dienstleistungen\/cmc-analyse-und-qualitaetskontrolle\/methodenentwicklung-und-validierung\/\" data-wpel-link=\"internal\">Validierung bioanalytischer Methoden<\/a> .<\/strong><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Die FDA hat eine Leitlinie f\u00fcr die Industrie mit dem  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":27134,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[254],"tags":[],"class_list":["post-27132","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Neue FDA-Leitlinien zur Validierung bioanalytischer Methoden | Kymos<\/title>\n<meta name=\"description\" content=\"Erfahren Sie mehr \u00fcber die neue Leitlinie f\u00fcr die Industrie mit dem Titel \u201eBioanalytische Methodenvalidierung\u201c, die von der FDA herausgegeben wurde.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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