{"id":23200,"date":"2022-06-22T08:54:06","date_gmt":"2022-06-22T06:54:06","guid":{"rendered":"https:\/\/kymos.com\/news\/estudios-de-bioequivalencia-en-europa\/"},"modified":"2025-08-07T20:33:53","modified_gmt":"2025-08-07T18:33:53","slug":"estudios-de-bioequivalencia-en-europa","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/estudios-de-bioequivalencia-en-europa\/","title":{"rendered":"Estudios de bioequivalencia en Europa"},"content":{"rendered":"

Los estudios de bioequivalencia est\u00e1n dise\u00f1ados para demostrar que dos medicamentos son equivalentes y sustituibles. Pero aunque los medicamentos son reemplazables, los proveedores de estudios de bioequivalencia no lo son. <\/span><\/p>\n

Digna Tost, responsable del Departamento de Bioan\u00e1lisis de Mol\u00e9culas Peque\u00f1as de Kymos, resume por qu\u00e9 Kymos es el socio adecuado para proyectos de bioequivalencia:<\/span><\/p>\n

\n

Nuestros clientes buscan una CRO con altos est\u00e1ndares de calidad, plazos ajustados y precios competitivos. Todo eso lo encuentran en Kymos. En Kymos, tenemos los m\u00e1s altos est\u00e1ndares de calidad y cumplimiento regulatorio de nuestros proyectos de bioequivalencia.<\/strong> Todos los estudios cl\u00ednicos se realizan exclusivamente en centros europeos de prestigio. Adem\u00e1s, nosotros y nuestros socios estamos inspeccionados por la FDA y la EMA y cumplimos con las normas de BPC\/BPL. Gracias a d\u00e9cadas de experiencia y a una s\u00f3lida colaboraci\u00f3n, trabajamos con rapidez y eficiencia. <\/span><\/p>\n<\/blockquote>\n

Kymos ofrece un servicio integral para estudios de bioequivalencia. Desde la gesti\u00f3n de ensayos cl\u00ednicos, el bioan\u00e1lisis y la evaluaci\u00f3n farmacocin\u00e9tica hasta las pruebas de lotes y la autorizaci\u00f3n de comercializaci\u00f3n en la UE de medicamentos para su uso en ensayos cl\u00ednicos. Digna Tost ofrece una visi\u00f3n general de los servicios de gesti\u00f3n de ensayos cl\u00ednicos que Kymos ofrece para estudios de bioequivalencia: <\/span><\/p>\n

\n

En la gesti\u00f3n de ensayos cl\u00ednicos, le ofrecemos un paquete integral.<\/strong> En colaboraci\u00f3n con nuestros socios cl\u00ednicos, Kymos ofrece apoyo desde las primeras etapas de los estudios de bioequivalencia: redacci\u00f3n de protocolos cl\u00ednicos, gesti\u00f3n de las presentaciones a comit\u00e9s de \u00e9tica y autoridades reguladoras, y la gesti\u00f3n de los seguros correspondientes. Log\u00edsticamente, coordinamos el suministro de productos de prueba y de referencia, as\u00ed como el env\u00edo de muestras a las instalaciones bioanal\u00edticas. Somos una empresa con certificaci\u00f3n GMP y una autorizaci\u00f3n de importaci\u00f3n para medicamentos comercializados e IPM, lo que nos permite importar medicamentos de referencia y de prueba desde pa\u00edses no pertenecientes a la UE para realizar ensayos cl\u00ednicos. Adem\u00e1s, ofrecemos monitorizaci\u00f3n de ensayos cl\u00ednicos. <\/span><\/p>\n<\/blockquote>\n

Sin embargo, Kymos se centra principalmente en el campo bioanal\u00edtico. Durante las \u00faltimas d\u00e9cadas, Kymos ha desarrollado con \u00e9xito una amplia gama de m\u00e9todos bioanal\u00edticos validados en diferentes matrices y con distintos rangos. Gracias a esta experiencia, podemos actuar con rapidez y eficiencia, minimizando los costos para nuestros clientes. La lista de m\u00e9todos, con una pr\u00e1ctica funci\u00f3n de b\u00fasqueda, se encuentra en nuestra p\u00e1gina de servicios: Estudios de Bioequivalencia<\/a> .<\/strong> Adem\u00e1s, contamos con una gran cantidad de m\u00e9todos predise\u00f1ados que validamos gratuitamente para nuestros clientes. Para obtener m\u00e1s informaci\u00f3n, p\u00f3ngase en contacto con nuestros gerentes de servicio<\/a> . <\/span><\/p>\n

Finalmente, Digna Tost revela lo que hace que Kymos sea especial a sus ojos:<\/span><\/p>\n

\n

En mi experiencia previa en ensayos cl\u00ednicos, siempre he constatado que una gesti\u00f3n cl\u00ednica rigurosa y la m\u00e1xima calidad son cruciales para el \u00e9xito de un estudio de bioequivalencia. Me complace enormemente que Kymos priorice precisamente esto y que tengamos tantos clientes satisfechos.<\/span><\/p>\n<\/blockquote>\n<\/div>

\"bioanalysis<\/span><\/div>

Digna Tost y el Departamento de Bioan\u00e1lisis de Mol\u00e9culas Peque\u00f1as<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":21934,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[62],"class_list":["post-23200","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisis","tag-joan"],"acf":[],"yoast_head":"\nSocio de confianza para estudios de bioequivalencia | Grupo Kymos<\/title>\n<meta name=\"description\" content=\"Los estudios de bioequivalencia en Kymos se realizan exclusivamente en centros europeos de prestigio. Cumplen con las normativas FDA\/EMA. 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