{"id":57335,"date":"2022-05-24T11:06:41","date_gmt":"2022-05-24T09:06:41","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/pedido-de-medicamento-en-investigacion-para-estudios-clinicos\/"},"modified":"2022-05-24T11:06:41","modified_gmt":"2022-05-24T09:06:41","slug":"pedido-de-medicamento-en-investigacion-para-estudios-clinicos","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/es\/online-course\/pedido-de-medicamento-en-investigacion-para-estudios-clinicos\/","title":{"rendered":"Pedido de medicamento en investigaci\u00f3n para estudios cl\u00ednicos"},"content":{"rendered":"<p>Un medicamento en investigaci\u00f3n (IMP) es una formulaci\u00f3n farmac\u00e9utica de una sustancia activa que ha avanzado a la fase de ensayo cl\u00ednico del descubrimiento de f\u00e1rmacos. Tras los estudios preliminares, teniendo en cuenta los sistemas de administraci\u00f3n del f\u00e1rmaco y la idoneidad seg\u00fan las propiedades fisicoqu\u00edmicas del compuesto, se presenta una formulaci\u00f3n para su uso en ensayos cl\u00ednicos. Los IMP solo deben utilizarse en entornos de ensayo cl\u00ednico.  <\/p>\n<p>Este curso le presenta la necesidad, el suministro, la manipulaci\u00f3n y la eliminaci\u00f3n de los IMP, incluido el proceso de autorizaci\u00f3n. Estos conocimientos son necesarios para promotores, investigadores y quienes participan en la gesti\u00f3n de la investigaci\u00f3n cl\u00ednica. <\/p>\n<p>En este curso, ofrecemos una s\u00edntesis del tema mediante una experiencia online interactiva. Este material ha sido elaborado por un equipo de expertos en Asuntos Regulatorios con una titulaci\u00f3n de Northeastern University, Boston, y pilotado por un miembro s\u00e9nior capaz de articular la teor\u00eda con la pr\u00e1ctica. <\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>Programa<\/h3>\n<p>&nbsp;<\/p>\n<p><strong>Introducci\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 1: Informaci\u00f3n sobre los IMP<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 2: Suministro y manipulaci\u00f3n de los IMP<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Almacenamiento<\/li>\n<li>Responsabilidad<\/li>\n<li>Documentaci\u00f3n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 3: Cantidades de IMP necesarias para los ensayos cl\u00ednicos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Desarrollo del proceso de fabricaci\u00f3n<\/li>\n<li>Composici\u00f3n del IMP<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 4: Ensayos cl\u00ednicos<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Fase I<\/li>\n<li>Fase II<\/li>\n<li>Fase III<\/li>\n<li>Fase IV<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 5: Control de calidad<\/strong><\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Estudio de estabilidad<\/li>\n<li>Gesti\u00f3n de materias primas<\/li>\n<li>Reclamaciones<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Lecci\u00f3n 6: Eliminaci\u00f3n segura de los IMP no utilizados<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Glosario<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Definiciones<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Conclusi\u00f3n<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Cuestionario<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Un medicamento en investigaci\u00f3n (IMP) es una formulaci\u00f3n farmac\u00e9utica de una sustancia activa que ha avanzado a la fase de ensayo cl\u00ednico del descubrimiento de f\u00e1rmacos. Tras los estudios preliminares, teniendo en cuenta los sistemas de administraci\u00f3n del f\u00e1rmaco y la idoneidad seg\u00fan las propiedades fisicoqu\u00edmicas del compuesto, se presenta una formulaci\u00f3n para su uso [&hellip;]<\/p>\n","protected":false},"featured_media":43650,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[275,270,269],"product_tag":[],"class_list":{"0":"post-57335","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-gcp-ensayos-clinicos","7":"product_cat-organizacion-de-investigacion-por-contrato-cro","8":"product_cat-productos-farmaceuticos","10":"first","11":"instock","12":"taxable","13":"shipping-taxable","14":"purchasable","15":"product-type-simple"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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