{"id":27064,"date":"2018-02-13T12:04:59","date_gmt":"2018-02-13T11:04:59","guid":{"rendered":"https:\/\/kymos.com\/news\/zweckmaessige-bioanalytische-methoden-wissenschaftliche-validierung\/"},"modified":"2018-02-13T12:04:59","modified_gmt":"2018-02-13T11:04:59","slug":"zweckmaessige-bioanalytische-methoden-wissenschaftliche-validierung","status":"publish","type":"post","link":"https:\/\/kymos.com\/de\/news\/zweckmaessige-bioanalytische-methoden-wissenschaftliche-validierung\/","title":{"rendered":"Zweckm\u00e4\u00dfige bioanalytische Methoden: wissenschaftliche Validierung"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">Die Kriterien f\u00fcr bioanalytische Methoden haben sich in den letzten 25 Jahren deutlich weiterentwickelt. Die Harmonisierung der Anforderungen an bioanalytische Methoden begann 1990 im Rahmen der AAPS- und FDA-Konferenzen in Crystal City. Die zweite Konferenz in Crystal City im Jahr 2000 legte den Grundstein f\u00fcr die FDA-Leitlinie zur Validierung bioanalytischer Methoden von 2001. 2011 ver\u00f6ffentlichte die EMA ihre eigene Leitlinie zur Validierung bioanalytischer Methoden. Diese enth\u00e4lt Empfehlungen f\u00fcr die Validierung bioanalytischer Methoden zur Messung von Wirkstoffkonzentrationen in biologischen Matrices, die in tierexperimentellen toxikokinetischen Studien und in allen Phasen klinischer Pr\u00fcfungen gewonnen werden. Diese Leitlinien harmonisierten die Validierung bioanalytischer Methoden in pr\u00e4klinischen, klinischen und Bio\u00e4quivalenzstudien. Die Anforderungen zur Erf\u00fcllung der Leitlinie sind jedoch kostspielig und zeitaufw\u00e4ndig und entsprechen nicht den Bed\u00fcrfnissen der Industrie, insbesondere wenn bioanalytische Assays f\u00fcr Entscheidungen mit geringer Relevanz in fr\u00fchen Phasen der Arzneimittelentwicklung oder f\u00fcr spezielle Matrices eingesetzt werden.     <\/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<div>\n<p><span style=\"font-size: 14pt;\">Seit 2006 ist das Konzept <strong>des zweckdienlichen<\/strong> Ansatzes fester Bestandteil der bioanalytischen Diskussion, nachdem in Crystal City III ein gestuftes Verfahren zur Validierung bioanalytischer Methoden vorgeschlagen wurde. Dieses gestufte Verfahren sieht verschiedene Stufen der <strong>wissenschaftlichen Validierung<\/strong> als Alternative zur Anwendung etablierter regulatorischer Validierungsprinzipien vor. Der flexiblere Ansatz erm\u00f6glicht die Unterteilung der Methodenleistung und -bewertung in vier absteigende Stufen, abh\u00e4ngig vom Verwendungszweck der bioanalytischen Daten: 1) Validierung f\u00fcr regulatorische Studien, 2) Qualifizierung, 3) Forschung und 4) Screening.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">K\u00fcrzlich schlugen Branchenvertreter (im Rahmen des Europ\u00e4ischen Bioanalytischen Forums) vor, diesen gestaffelten Ansatz in <strong>wissenschaftliche Validierung<\/strong> umzubenennen. Ziel ist es, die Qualit\u00e4t der durch diese alternativen Validierungsworkflows generierten Daten zu betonen und gleichzeitig Wissenschaft und Ressourcen zu optimieren. Sie definierten eine praktische Anwendung dieses Konzepts in f\u00fcnf Schl\u00fcsselbereichen der bioanalytischen Unterst\u00fctzung: 1) Quantifizierung von Metaboliten in der fr\u00fchen Entwicklungsphase (wie in Crystal City III empfohlen), 2) Urinanalyse in allen Entwicklungsstadien, 3) Gewebeanalyse (Homogenatanalyse) ebenfalls in allen Entwicklungsstadien, 4) Klinische Studien in fr\u00fchen Phasen der Arzneimittelentwicklung und 5) Nicht-zulassungsrelevante pr\u00e4klinische GLP-Studien in der fr\u00fchen Phase.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Der Qualifizierungsplan f\u00fcr <strong>eine zweckm\u00e4\u00dfige<\/strong> wissenschaftliche Validierung sollte hinreichend begr\u00fcndet sein, um die Studienziele mit einem angemessenen Ma\u00df an Datenzuverl\u00e4ssigkeit und -qualit\u00e4t zu erreichen.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Die Kriterien f\u00fcr bioanalytische Methoden haben sich in den letzten  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":27066,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[254],"tags":[],"class_list":["post-27064","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 v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validierung anwendungsgerechter bioanalytischer Methoden | Kymos-Gruppe<\/title>\n<meta name=\"description\" content=\"Erfahren Sie mehr \u00fcber die wissenschaftliche Validierung zweckm\u00e4\u00dfiger bioanalytischer Methoden im neuen Blogbeitrag von Kymos.\" \/>\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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