{"id":27136,"date":"2018-05-25T12:14:44","date_gmt":"2018-05-25T10:14:44","guid":{"rendered":"https:\/\/kymos.com\/news\/nouvelles-recommandations-de-la-fda-sur-la-validation-des-methodes-bioanalytiques\/"},"modified":"2018-05-25T12:14:44","modified_gmt":"2018-05-25T10:14:44","slug":"nouvelles-recommandations-de-la-fda-sur-la-validation-des-methodes-bioanalytiques","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/nouvelles-recommandations-de-la-fda-sur-la-validation-des-methodes-bioanalytiques\/","title":{"rendered":"Nouvelles recommandations de la FDA sur la validation des m\u00e9thodes bioanalytiques"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">La FDA a publi\u00e9 un guide \u00e0 l&rsquo;intention de l&rsquo;industrie intitul\u00e9 \u00ab <strong>Validation des m\u00e9thodes bioanalytiques<\/strong> \u00bb. Ce guide remplace le projet de guide publi\u00e9 en septembre 2013 et tient compte des progr\u00e8s scientifiques et technologiques r\u00e9alis\u00e9s dans le domaine de la validation des m\u00e9thodes bioanalytiques.   <\/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;\">Les m\u00e9thodes bioanalytiques fournissent des donn\u00e9es essentielles pour \u00e9tayer l&rsquo;innocuit\u00e9 et l&rsquo;efficacit\u00e9 des m\u00e9dicaments et des produits biologiques. Le guide final d\u00e9crit les \u00e9l\u00e9ments de d\u00e9veloppement et de validation des m\u00e9thodes bioanalytiques pour les dosages chromatographiques ou de liaison de ligands, n\u00e9cessaires pour garantir la qualit\u00e9 et la fiabilit\u00e9 des donn\u00e9es pharmacocin\u00e9tiques et de biomarqueurs g\u00e9n\u00e9r\u00e9es. Il explique \u00e9galement comment \u00e9valuer les nouvelles technologies analytiques et comment valider les pr\u00e9l\u00e8vements de sang s\u00e9ch\u00e9 et les kits commerciaux r\u00e9utilis\u00e9s pour le d\u00e9veloppement de m\u00e9dicaments. Les tableaux de r\u00e9f\u00e9rence inclus dans le guide peuvent aider les promoteurs \u00e0 valider les m\u00e9thodes et \u00e0 documenter les rapports d&rsquo;\u00e9tude en vue de leur demande d&rsquo;autorisation de mise sur le march\u00e9 aupr\u00e8s de la FDA.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Le guide final se trouve ici&nbsp;: <strong><a href=\"https:\/\/kymos.com\/fr\/services\/analyse-cmc-et-controle-qualite\/developpement-et-validation-de-methodes\/\" data-wpel-link=\"internal\">Validation des m\u00e9thodes bioanalytiques<\/a> .<\/strong><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La FDA a publi\u00e9 un guide \u00e0 l&rsquo;intention de l&rsquo;industrie  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":27138,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[257],"tags":[],"class_list":["post-27136","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>Nouvelles recommandations de la FDA sur la validation des m\u00e9thodes bioanalytiques | Kymos<\/title>\n<meta name=\"description\" content=\"Pour en savoir plus, consultez les nouvelles lignes directrices destin\u00e9es \u00e0 l&#039;industrie et intitul\u00e9es \u00ab Validation des m\u00e9thodes bioanalytiques \u00bb, publi\u00e9es par la FDA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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