{"id":22724,"date":"2020-02-26T11:04:29","date_gmt":"2020-02-26T10:04:29","guid":{"rendered":"https:\/\/kymos.com\/news\/bioanalisi-harmonitzacio-experiencia-i-bones-practiques\/"},"modified":"2020-02-26T11:04:29","modified_gmt":"2020-02-26T10:04:29","slug":"bioanalisi-harmonitzacio-experiencia-i-bones-practiques","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/bioanalisi-harmonitzacio-experiencia-i-bones-practiques\/","title":{"rendered":"Bioan\u00e0lisi: Harmonitzaci\u00f3, Experi\u00e8ncia i Bones Pr\u00e0ctiques"},"content":{"rendered":"

La import\u00e0ncia de l’harmonitzaci\u00f3 de la ICH M10<\/strong><\/span><\/h3>\n
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La nostra cap de bioan\u00e0lisi, Digna Tost, t\u00e9 30 anys d’experi\u00e8ncia treballant en solucions de bioan\u00e0lisi. Aqu\u00ed, comenta l’harmonitzaci\u00f3 actual de les directrius bioanal\u00edtiques globals de l’ICH i el valor afegit de tenir un equip s\u00f2lid i mantenir les bones pr\u00e0ctiques. <\/span><\/p>\n

S’han publicat les actes M10 del Consell Internacional d’Harmonitzaci\u00f3 (ICH) per millorar la coher\u00e8ncia de les dades bioanal\u00edtiques i abordar els est\u00e0ndards divergents entre diferents parts del m\u00f3n. Amb la bioan\u00e0lisi cada cop m\u00e9s internacionalitzada, \u00e9s important coordinar les directrius reguladores. Aqu\u00ed, Digna Tost ofereix consells sobre com complir-les a nivell mundial: <\/span><\/p>\n

\u00abEn bioan\u00e0lisi, la regulaci\u00f3 global \u00e9s un comen\u00e7ament, per\u00f2 les bones pr\u00e0ctiques marquen la difer\u00e8ncia\u00bb, afirma. <\/em><\/span><\/p>\n

Tant el seguiment del compliment normatiu per part de l’autoritat de cada pa\u00eds com la seva execuci\u00f3 per part de la CRO s\u00f3n un repte a causa de les difer\u00e8ncies entre pa\u00efsos. Les ag\u00e8ncies reguladores han rebutjat projectes per inexactitud en m\u00faltiples ocasions, per la qual cosa \u00e9s important triar l’empresa adequada a l’hora de considerar la bioan\u00e0lisi. <\/span><\/p>\n

Les nostres solucions de bioan\u00e0lisi<\/strong><\/span>
\nA KYMOS, Digna i el seu departament de bioan\u00e0lisi, ben consolidat, col\u00b7laboren amb els clients per oferir bioan\u00e0lisi de primera classe a nivell expert. Amb una experi\u00e8ncia multidisciplin\u00e0ria combinada, l’equip de Digna ent\u00e9n tot el proc\u00e9s de fabricaci\u00f3 farmac\u00e8utica, des de les fases precl\u00edniques i cl\u00edniques fins a l’aprovaci\u00f3 final i els estudis postcomercialitzaci\u00f3. <\/span><\/p>\n

Es preveu que la guia ICH M10<\/a> s’adopti al novembre de 2020 per proporcionar directrius clares sobre com aconseguir an\u00e0lisis bioanal\u00edtiques. Si voleu millorar la qualitat, la coher\u00e8ncia i la fiabilitat de les dades bioanal\u00edtiques o el suport normatiu, Digna recomana consultar les actes de la darrera assemblea de l’ICH o contactar amb Kymos al +34 935 481 848. <\/span><\/p>\n

Feu clic aqu\u00ed per llegir m\u00e9s sobre les nostres solucions de bioan\u00e0lisi per a mol\u00e8cules petites<\/a> , productes biol\u00f2gics i biosimilars.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

La import\u00e0ncia de l’harmonitzaci\u00f3 de la ICH M10 La nostra […]<\/p>\n","protected":false},"author":6,"featured_media":14970,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[95],"tags":[],"class_list":["post-22724","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisi"],"acf":[],"yoast_head":"\nBioan\u00e0lisi: Harmonitzaci\u00f3, Experi\u00e8ncia i Bones Pr\u00e0ctiques<\/title>\n<meta name=\"description\" content=\"Apr\u00e8n m\u00e9s sobre l'harmonitzaci\u00f3 que s'acosta al camp de la bioan\u00e0lisi amb les solucions i bones pr\u00e0ctiques de l'ICH M10 i Kymos.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/ca\/news\/bioanalisi-harmonitzacio-experiencia-i-bones-practiques\/\" \/>\n<meta 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