{"id":23116,"date":"2019-04-28T13:38:43","date_gmt":"2019-04-28T11:38:43","guid":{"rendered":"https:\/\/kymos.com\/news\/calidad-y-equivalencia-de-productos-topicos\/"},"modified":"2019-04-28T13:38:43","modified_gmt":"2019-04-28T11:38:43","slug":"calidad-y-equivalencia-de-productos-topicos","status":"publish","type":"post","link":"https:\/\/kymos.com\/es\/news\/calidad-y-equivalencia-de-productos-topicos\/","title":{"rendered":"Calidad y equivalencia de productos t\u00f3picos"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">El 18 de octubre de 2018, la EMA public\u00f3 el <a href=\"https:\/\/www.ema.europa.eu\/documents\/scientific-guideline\/draft-guideline-quality-equivalence-topical-products_en.pdf\" data-wpel-link=\"external\">Borrador de la Gu\u00eda sobre Calidad y Equivalencia de Productos T\u00f3picos<\/a> . El 30 de junio de 2019, finalizar\u00e1 el per\u00edodo de consulta y se espera que entre en vigor a finales de a\u00f1o. La gu\u00eda establece claramente que las aplicaciones regulatorias basadas en la literatura para demostrar la seguridad y eficacia deben estar respaldadas por datos de equivalencia de la formulaci\u00f3n. Al mismo tiempo, proporciona detalles de los modelos <i>in vivo<\/i> e <i>in vitro<\/i> que pueden sustituir a los datos cl\u00ednicos y cu\u00e1ndo son aplicables las bioexenciones. La gu\u00eda cubre espec\u00edficamente: <b>prueba de liberaci\u00f3n <i>in vitro<\/i><\/b> ( <b>IVRT<\/b> ), <b>estudios de permeaci\u00f3n cut\u00e1nea <i>in vitro<\/i><\/b> ( <b>IVPT<\/b> ), muestreo del estrato c\u00f3rneo mediante desprendimiento de cinta y ensayo de vasoconstricci\u00f3n para corticosteroides.    <\/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<p><span style=\"font-size: 14pt;\"><b>La IVRT<\/b> no es un modelo del rendimiento <i>in vivo<\/i> de la formulaci\u00f3n, pero puede utilizarse como atributo de calidad para la liberaci\u00f3n del lote y la especificaci\u00f3n de la vida \u00fatil. Su objetivo es evaluar la velocidad y la extensi\u00f3n de la liberaci\u00f3n de una sustancia activa en la formulaci\u00f3n a trav\u00e9s de una membrana. Los par\u00e1metros a evaluar son la velocidad de liberaci\u00f3n del f\u00e1rmaco, la cantidad acumulada y el tiempo de retardo. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><b>La IVPT<\/b> utiliza piel humana en estudios discriminatorios para demostrar la equivalencia entre una formulaci\u00f3n de prueba y un comparador conocido, lo que podr\u00eda evitar ensayos cl\u00ednicos con criterio de valoraci\u00f3n de eficacia. Los estudios piloto y pivotales deben realizarse de acuerdo con la norma ICH E8 en cuanto a aleatorizaci\u00f3n y enmascaramiento. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><b>La IVPT<\/b> tambi\u00e9n puede utilizarse para evaluar la falta de absorci\u00f3n en sustancias farmacol\u00f3gicas, cosm\u00e9ticos o biocidas con actividad local que no deber\u00edan absorberse por razones de seguridad.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><b>La IVRT<\/b> y <b>la IVPT<\/b> se realizan generalmente mediante c\u00e9lulas de difusi\u00f3n vertical, siendo las m\u00e1s comunes las llamadas c\u00e9lulas de Franz. El uso de instrumentos automatizados reduce la variabilidad, especialmente al utilizar piel de donantes, y con el software adecuado, proporciona resultados fiables que cumplen con la norma 21 CFR parte 11. <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Desde el punto de vista de la calidad, el uso de pruebas in vitro para productos t\u00f3picos es una herramienta importante para desarrollar formulaciones consistentes durante su ciclo de vida y se convertir\u00e1 en un atributo para certificar la calidad y la homogeneidad de los lotes de fabricaci\u00f3n. Desde la perspectiva de la equivalencia, abre la puerta al registro de productos gen\u00e9ricos a precios asequibles y tendr\u00e1 un gran impacto en los pr\u00f3ximos a\u00f1os para el acceso al mercado de estos productos. <\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>El 18 de octubre de 2018, la EMA public\u00f3 el  [&#8230;]<\/p>\n","protected":false},"author":6,"featured_media":21711,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181,183],"tags":[],"class_list":["post-23116","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalisis","category-cmc-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Calidad y equivalencia de productos t\u00f3picos | Kymos<\/title>\n<meta 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