{"id":23094,"date":"2018-02-13T12:04:59","date_gmt":"2018-02-13T11:04:59","guid":{"rendered":"https:\/\/kymos.com\/news\/metodos-bioanaliticos-adecuados-al-proposito-validacion-cientifica\/"},"modified":"2018-02-13T12:04:59","modified_gmt":"2018-02-13T11:04:59","slug":"metodos-bioanaliticos-adecuados-al-proposito-validacion-cientifica","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/metodos-bioanaliticos-adecuados-al-proposito-validacion-cientifica\/","title":{"rendered":"M\u00e9todos bioanal\u00edticos adecuados al prop\u00f3sito: validaci\u00f3n cient\u00edfica"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">En los \u00faltimos 25 a\u00f1os, los criterios requeridos para los m\u00e9todos bioanal\u00edticos han evolucionado significativamente. La armonizaci\u00f3n de los requisitos de los m\u00e9todos bioanal\u00edticos comenz\u00f3 en 1990 durante las Reuniones Crystal City de la AAPS y la FDA. En 2000, la Reuni\u00f3n Crystal City II sent\u00f3 las bases de la Gu\u00eda de la FDA de 2001 sobre Validaci\u00f3n de M\u00e9todos Bioanal\u00edticos. En 2011, la EMA lanz\u00f3 su propia gu\u00eda sobre validaci\u00f3n de m\u00e9todos bioanal\u00edticos que proporciona recomendaciones para la validaci\u00f3n de m\u00e9todos bioanal\u00edticos aplicados para medir concentraciones de f\u00e1rmacos en matrices biol\u00f3gicas obtenidas en estudios toxicocin\u00e9ticos animales y todas las fases de ensayos cl\u00ednicos. Estas gu\u00edas armonizaron la validaci\u00f3n de m\u00e9todos bioanal\u00edticos involucrados en estudios precl\u00ednicos, cl\u00ednicos y de bioequivalencia. Sin embargo, los requisitos para cumplir con la gu\u00eda son costosos y requieren mucho tiempo y no coinciden con las necesidades de la industria cuando los ensayos bioanal\u00edticos est\u00e1n dise\u00f1ados para tomar decisiones de baja relevancia en fases tempranas del desarrollo de f\u00e1rmacos y cuando se utilizan en matrices especiales.     <\/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;\">Desde 2006, el concepto de enfoque de <strong>ajuste al prop\u00f3sito<\/strong> se ha integrado en el debate bioanal\u00edtico cuando se propuso un enfoque escalonado para la validaci\u00f3n de m\u00e9todos bioanal\u00edticos en Crystal City III. Este enfoque escalonado implica diferentes niveles de <strong>validaci\u00f3n cient\u00edfica<\/strong> como alternativa a la aplicaci\u00f3n de los principios de validaci\u00f3n regulatoria establecidos. Este enfoque m\u00e1s flexible permite dividir el rendimiento y la evaluaci\u00f3n del m\u00e9todo en cuatro niveles decrecientes, seg\u00fan el prop\u00f3sito final de los datos bioanal\u00edticos: 1) Validaci\u00f3n, destinada a estudios regulatorios; 2) Calificaci\u00f3n; 3) Investigaci\u00f3n; y 4) Selecci\u00f3n.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">M\u00e1s recientemente, representantes de la industria (dentro del Foro Bioanal\u00edtico Europeo) propusieron redefinir este enfoque escalonado como <strong>validaci\u00f3n cient\u00edfica,<\/strong> con el objetivo de enfatizar la calidad de los datos generados por estos flujos de trabajo de validaci\u00f3n alternativos, a la vez que se mantiene el objetivo de optimizar la ciencia y los recursos. Definieron una aplicaci\u00f3n pr\u00e1ctica de este concepto en cinco \u00e1reas clave de apoyo bioanal\u00edtico: 1) Cuantificaci\u00f3n de metabolitos en el desarrollo temprano (como se recomienda en Crystal City III), 2) An\u00e1lisis de orina en todas las etapas de desarrollo, 3) An\u00e1lisis de tejido (homogenado) tambi\u00e9n en todas las etapas de desarrollo, 4) Estudios cl\u00ednicos en las primeras etapas del desarrollo de f\u00e1rmacos, y 5) Estudios precl\u00ednicos tempranos no cruciales de BPL.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">El plan de calificaci\u00f3n para la validaci\u00f3n cient\u00edfica <strong>adecuada al prop\u00f3sito<\/strong> debe estar adecuadamente justificado para cumplir los objetivos del estudio con un nivel adecuado de confiabilidad y calidad de los datos.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>En los \u00faltimos 25 a\u00f1os, los criterios requeridos para los  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":21695,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[],"class_list":["post-23094","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisis"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validaci\u00f3n de m\u00e9todos bioanal\u00edticos adaptados a cada prop\u00f3sito | Grupo Kymos<\/title>\n<meta name=\"description\" content=\"Obtenga m\u00e1s informaci\u00f3n sobre la validaci\u00f3n cient\u00edfica de m\u00e9todos bioanal\u00edticos adaptados a su prop\u00f3sito con la nueva publicaci\u00f3n del blog de 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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