{"id":22704,"date":"2018-02-13T12:04:59","date_gmt":"2018-02-13T11:04:59","guid":{"rendered":"https:\/\/kymos.com\/news\/metodes-bioanalitics-adequats-a-lobjectiu-validacio-cientifica\/"},"modified":"2018-02-13T12:04:59","modified_gmt":"2018-02-13T11:04:59","slug":"metodes-bioanalitics-adequats-a-lobjectiu-validacio-cientifica","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/metodes-bioanalitics-adequats-a-lobjectiu-validacio-cientifica\/","title":{"rendered":"M\u00e8todes bioanal\u00edtics adequats a l&#8217;objectiu: validaci\u00f3 cient\u00edfica"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">Durant els darrers 25 anys, els criteris requerits per als m\u00e8todes bioanal\u00edtics han evolucionat significativament. L&#8217;harmonitzaci\u00f3 dels requisits dels m\u00e8todes bioanal\u00edtics va comen\u00e7ar el 1990 durant les reunions de l&#8217;AAPS i la FDA a Crystal City. L&#8217;any 2000, la reuni\u00f3 de Crystal City II va establir les bases de la Guia de la FDA sobre la validaci\u00f3 de m\u00e8todes bioanal\u00edtics del 2001. El 2011, l&#8217;EMA va llan\u00e7ar la seva pr\u00f2pia guia sobre la validaci\u00f3 de m\u00e8todes bioanal\u00edtics que proporciona recomanacions per a la validaci\u00f3 dels m\u00e8todes bioanal\u00edtics aplicats per mesurar les concentracions de f\u00e0rmacs en matrius biol\u00f2giques obtingudes en estudis toxicocin\u00e8tics en animals i en totes les fases dels assajos cl\u00ednics. Aquestes directrius van harmonitzar la validaci\u00f3 del m\u00e8tode bioanal\u00edtic implicada en estudis precl\u00ednics, cl\u00ednics i de bioequival\u00e8ncia. Tanmateix, els requisits per complir la guia s\u00f3n costosos i requereixen molt de temps, i no coincideixen amb les necessitats de la ind\u00fastria quan els assaigs bioanal\u00edtics estan dissenyats per prendre decisions de baixa rellev\u00e0ncia en fases anteriors del desenvolupament de f\u00e0rmacs i quan s&#8217;utilitzen en matrius especials.     <\/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;\">Des del 2006, el concepte d&#8217;enfocament <strong>d&#8217;adequaci\u00f3 a l&#8217;objectiu<\/strong> ha passat a formar part del debat bioanal\u00edtic quan es va proposar un enfocament per nivells per a la validaci\u00f3 de m\u00e8todes bioanal\u00edtics a Crystal City III. El concepte d&#8217;enfocament per nivells implica diferents nivells de <strong>validaci\u00f3 cient\u00edfica<\/strong> com a alternativa a l&#8217;aplicaci\u00f3 completa dels principis de validaci\u00f3 reglament\u00e0ria establerts. Aquest enfocament m\u00e9s flexible permet dividir entre quatre nivells decreixents de rendiment i avaluaci\u00f3 del m\u00e8tode segons l&#8217;objectiu final de les dades bioanal\u00edtiques: 1) Validaci\u00f3, destinada a estudis reglamentaris, 2) Qualificaci\u00f3, 3) Recerca i 4) Cribratge.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">M\u00e9s recentment, representants de la ind\u00fastria (dins del F\u00f2rum Bioanal\u00edtic Europeu) van proposar canviar la marca d&#8217;aquest enfocament per nivells a <strong>validaci\u00f3 cient\u00edfica<\/strong> amb l&#8217;objectiu d&#8217;emfatitzar la qualitat de les dades generades per aquests fluxos de treball de validaci\u00f3 alternatius, tot mantenint l&#8217;objectiu d&#8217;optimitzar la ci\u00e8ncia i els recursos. Van definir una aplicaci\u00f3 pr\u00e0ctica d&#8217;aquest concepte en cinc \u00e0rees clau de suport bioanal\u00edtic: 1) Quantificaci\u00f3 de metab\u00f2lits en les primeres etapes del desenvolupament (tal com es recomana a Crystal City III), 2) An\u00e0lisi d&#8217;orina en totes les etapes del desenvolupament, 3) An\u00e0lisi de teixits (homogenats) tamb\u00e9 en totes les etapes del desenvolupament, 4) Estudis cl\u00ednics en les primeres etapes del desenvolupament de f\u00e0rmacs, i 5) Estudis precl\u00ednics BPL no fonamentals.      <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">El pla de qualificaci\u00f3 per a la validaci\u00f3 cient\u00edfica <strong>adequada a l&#8217;objectiu<\/strong> ha d&#8217;estar degudament justificat per complir els objectius de l&#8217;estudi amb un nivell adequat de fiabilitat i qualitat de les dades.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Durant els darrers 25 anys, els criteris requerits per als  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":14997,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95],"tags":[],"class_list":["post-22704","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validaci\u00f3 de m\u00e8todes bioanal\u00edtics adequats a l&#039;objectiu | Kymos Group<\/title>\n<meta name=\"description\" content=\"Apr\u00e8n m\u00e9s sobre la validaci\u00f3 cient\u00edfica dels m\u00e8todes bioanal\u00edtics adequats a l&#039;objectiu amb la nova entrada 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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