{"id":9942,"date":"2024-12-11T12:48:13","date_gmt":"2024-12-11T12:48:13","guid":{"rendered":"https:\/\/amarintech.com\/?p=9942"},"modified":"2024-12-11T12:56:56","modified_gmt":"2024-12-11T12:56:56","slug":"interchangeability-guidances-for-tds","status":"publish","type":"post","link":"https:\/\/amarintech.com\/es\/interchangeability-guidances-for-tds\/","title":{"rendered":"Gu\u00edas de Intercambiabilidad para Sistemas Transd\u00e9rmicos: Necesidad de Armonizaci\u00f3n"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9942\" class=\"elementor elementor-9942\">\n\t\t\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-c78867c elementor-section-height-min-height she-header-yes elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"c78867c\" data-element_type=\"section\" 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xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 1000 100\" preserveaspectratio=\"none\">\n\t<path class=\"elementor-shape-fill\" opacity=\"0.33\" d=\"M473,67.3c-203.9,88.3-263.1-34-320.3,0C66,119.1,0,59.7,0,59.7V0h1000v59.7 c0,0-62.1,26.1-94.9,29.3c-32.8,3.3-62.8-12.3-75.8-22.1C806,49.6,745.3,8.7,694.9,4.7S492.4,59,473,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" opacity=\"0.66\" d=\"M734,67.3c-45.5,0-77.2-23.2-129.1-39.1c-28.6-8.7-150.3-10.1-254,39.1 s-91.7-34.4-149.2,0C115.7,118.3,0,39.8,0,39.8V0h1000v36.5c0,0-28.2-18.5-92.1-18.5C810.2,18.1,775.7,67.3,734,67.3z\"\/>\n\t<path class=\"elementor-shape-fill\" d=\"M766.1,28.9c-200-57.5-266,65.5-395.1,19.5C242,1.8,242,5.4,184.8,20.6C128,35.8,132.3,44.9,89.9,52.5C28.6,63.7,0,0,0,0 h1000c0,0-9.9,40.9-83.6,48.1S829.6,47,766.1,28.9z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c82bb91\" data-id=\"c82bb91\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2e6195d elementor-widget elementor-widget-heading\" data-id=\"2e6195d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Gu\u00edas de Intercambiabilidad para Sistemas Transd\u00e9rmicos: Necesidad de Armonizaci\u00f3n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32d95f8 elementor-widget elementor-widget-text-editor\" data-id=\"32d95f8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d410b7a elementor-widget elementor-widget-heading\" data-id=\"d410b7a\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\"><p class=\"elementor-heading-title elementor-size-default\"><strong>Miguel Fortuny<\/strong><b> &#8211; <\/b>Gerente de Investigaci\u00f3n Cl\u00ednica<\/p><\/div><\/div><div id=\"gtx-trans\" style=\"position: absolute; left: 154px; top: 38px;\"><div class=\"gtx-trans-icon\">\u00a0<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-62b6c1f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"62b6c1f\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-97230eb\" data-id=\"97230eb\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a8f378 elementor-widget elementor-widget-text-editor\" data-id=\"5a8f378\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4><strong>Introducci\u00f3n:<\/strong><\/h4><p>Desde 2016, tanto la FDA como la EMA han actualizado sus gu\u00edas centrales para definir los requisitos y recomendaciones para evaluar la adhesi\u00f3n y la irritaci\u00f3n\/sensibilizaci\u00f3n cut\u00e1nea en sistemas de administraci\u00f3n transd\u00e9rmica, tanto para prop\u00f3sitos de ANDA como de NDA.<\/p><p>En la misma l\u00ednea, tanto COFEPRIS (M\u00e9xico) como ANVISA (Brasil) se han convertido en pioneros al lanzar sus gu\u00edas para la intercambiabilidad de parches desde 2015, tras varias rondas de discusiones con la industria farmac\u00e9utica para actualizar las normativas vigentes. En particular, Brasil ha publicado recientemente una gu\u00eda espec\u00edfica para productos relacionados con la presentaci\u00f3n de gen\u00e9ricos que contienen un antiparkinsoniano, en l\u00ednea con las gu\u00edas espec\u00edficas de productos que la FDA actualiza regularmente.<\/p><p>Al comparar estas gu\u00edas, se evidencian varias diferencias que podr\u00edan impedir que un conjunto de estudios presentado para respaldar una solicitud de comercializaci\u00f3n sea aprobado en un pa\u00eds espec\u00edfico.<\/p><p>Este art\u00edculo tiene como objetivo ofrecer una comparaci\u00f3n resumida destacando las principales diferencias en los requisitos para estudios cl\u00ednicos establecidos en dichas gu\u00edas.<\/p><p>\u00a0<\/p><h5><strong>Diferencias detectadas en los requisitos cl\u00ednicos de las gu\u00edas para un TDS gen\u00e9rico<\/strong><\/h5><ul><li><strong>Estudios requeridos para una presentaci\u00f3n de ANDA<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table width=\"623\"><tbody><tr><td width=\"98\"><p>Tema<\/p><\/td><td width=\"129\"><p>FDA<\/p><\/td><td width=\"129\"><p>EMA<\/p><\/td><td width=\"129\"><p>COFEPRIS<\/p><\/td><td width=\"139\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"98\"><p>Tipo de estudios<\/p><\/td><td width=\"129\"><p>Bioequivalencia<\/p><p>Adhesi\u00f3n (1)<sup>(1)<\/sup>,<\/p><p>Sensibilizaci\u00f3n y\/o Irritaci\u00f3n<\/p><\/td><td width=\"129\"><p>Bioequivalencia<\/p><p>Adhesi\u00f3n (1)<sup>(1, 4)<\/sup>,<\/p><p>Sensibilizaci\u00f3n, Irritaci\u00f3n,<\/p><p>Fototoxicidad<\/p><p>\u00a0<\/p><p>\u00a0<\/p><\/td><td width=\"129\"><p>Bioequivalencia<\/p><p>Adhesi\u00f3n (1)<sup>(1)<\/sup>,<\/p><p>Adhesi\u00f3n en actividades normales<sup>(3)<\/sup>,<\/p><p>Sensibilizaci\u00f3n y\/o Irritaci\u00f3n<\/p><\/td><td width=\"139\"><p>Farmacocin\u00e9tica(2) +<sup>(2)<\/sup> Adhesi\u00f3n (en el mismo estudio),<\/p><p>Sensibilizaci\u00f3n\/Irritaci\u00f3n<\/p><\/td><\/tr><\/tbody><\/table><p>La adhesi\u00f3n puede evaluarse en un estudio combinado BE+Adhesi\u00f3n o en un estudio espec\u00edfico.<\/p><p>Para ANVISA, el t\u00e9rmino Bioequivalencia comprende 3 estudios: Farmacocin\u00e9tica, Adhesi\u00f3n e Irritaci\u00f3n\/Sensibilizaci\u00f3n cut\u00e1nea.<\/p><p>COFEPRIS exige probar la resistencia del parche a duchas, cremas hidratantes y ejercicio f\u00edsico.<\/p><p>La agencia puede solicitar otros estudios espec\u00edficos.<\/p><ul><li><strong>Para Bioequivalencia<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table width=\"623\"><tbody><tr><td width=\"112\"><p>Tema<\/p><\/td><td width=\"114\"><p>FDA<\/p><\/td><td width=\"129\"><p>EMA<\/p><\/td><td width=\"129\"><p>COFEPRIS<\/p><\/td><td width=\"139\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"112\"><p>An\u00e1lisis de variabilidad<\/p><\/td><td width=\"114\"><p>Tratamiento, Periodo, Secuencia y Sujeto anidado en la secuencia<\/p><\/td><td width=\"129\"><p>Tratamiento, Periodo, Secuencia y Sujeto anidado en la secuencia<\/p><\/td><td width=\"129\"><p>Tratamiento, Periodo, Secuencia y Sujeto anidado en la secuencia<\/p><\/td><td width=\"139\"><p>Igual que FDA, pero incluye sitio de aplicaci\u00f3n<\/p><\/td><\/tr><tr><td width=\"112\"><p>Requisito de AUC parciales<\/p><\/td><td width=\"114\"><p>Depende del API considerado<\/p><\/td><td width=\"129\"><p>Depende del grado de acumulaci\u00f3n del f\u00e1rmaco<\/p><\/td><td width=\"129\"><p>No requerido<\/p><\/td><td width=\"139\"><p>Requerido (igual que EMA)<\/p><\/td><\/tr><\/tbody><\/table><p>\u00a0<\/p><p><strong>\u00a0<\/strong><\/p><ul><li><strong>Para Adhesi\u00f3n del Parche<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table><tbody><tr><td width=\"122\"><p>Tema Revisado<\/p><\/td><td width=\"126\"><p>FDA<\/p><\/td><td width=\"121\"><p>EMA<\/p><\/td><td width=\"122\"><p>COFEPRIS<\/p><\/td><td width=\"121\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"122\"><p>Criterios de evaluaci\u00f3n<\/p><\/td><td width=\"126\"><p>Puntaje promedio de adhesi\u00f3n<\/p><\/td><td width=\"121\"><p>Porcentaje de adhesi\u00f3n al final del intervalo de dosificaci\u00f3n<\/p><\/td><td width=\"122\"><p>Puntaje acumulativo de adhesi\u00f3n<\/p><\/td><td width=\"121\"><p>Igual que EMA<\/p><\/td><\/tr><tr><td width=\"122\"><p>Adhesi\u00f3n en actividades normales<\/p><\/td><td width=\"126\"><p>Recomendado<\/p><\/td><td width=\"121\"><p>No mencionado\u00a0<\/p><\/td><td width=\"122\"><p>Requerido<\/p><\/td><td width=\"121\"><p>No requerido<\/p><\/td><\/tr><tr><td width=\"122\"><p>Estad\u00edsticas para variables secundarias<\/p><\/td><td width=\"126\"><p>Descriptivas<\/p><\/td><td width=\"121\"><p>Descriptivas<\/p><\/td><td width=\"122\"><p>Descriptivas<\/p><\/td><td width=\"121\"><p>Descriptivas e inferenciales<\/p><\/td><\/tr><\/tbody><\/table><p><strong>\u00a0<\/strong><\/p><p><strong>\u00a0<\/strong><\/p><ul><li><strong>Para Irritaci\u00f3n\/Sensibilizaci\u00f3n<\/strong><\/li><\/ul><p><strong>\u00a0<\/strong><\/p><table><tbody><tr><td width=\"121\"><p>Tema Revisado<\/p><\/td><td width=\"133\"><p>FDA<\/p><\/td><td width=\"112\"><p>EMA<\/p><\/td><td width=\"122\"><p>COFEPRIS<\/p><\/td><td width=\"125\"><p>ANVISA<\/p><\/td><\/tr><tr><td width=\"121\"><p>Dise\u00f1o<\/p><\/td><td width=\"133\"><p>Un grupo, fase de inducci\u00f3n, descanso y desaf\u00edo<\/p><\/td><td width=\"112\"><p>Dos grupos (diferente tiempo de uso del parche), inducci\u00f3n, descanso y desaf\u00edo<\/p><\/td><td width=\"122\"><p>Igual que FDA<\/p><\/td><td width=\"125\"><p>Igual que FDA<\/p><p>\u00a0<\/p><p>(Formerly, it resembled EMA design)<\/p><\/td><\/tr><tr><td width=\"121\"><p>Definici\u00f3n de irritaci\u00f3n excesiva<\/p><\/td><td width=\"133\"><p>Puntaje combinado \u2265 3<\/p><\/td><td width=\"112\"><p>Puntaje combinado \u2265 4<\/p><\/td><td width=\"122\"><p>Puntaje 3-7 o cualquier respuesta d\u00e9rmica con otros efectos<\/p><\/td><td width=\"125\"><p>Igual que FDA<\/p><\/td><\/tr><tr><td width=\"121\"><p>Escala de respuesta d\u00e9rmica<\/p><\/td><td width=\"133\"><p>\u00a0Letras y n\u00fameros: A(0), B(1), C(2), F(3), etc.<\/p><\/td><td width=\"112\"><p>N\u00fameros del 0 al 4 (asignaci\u00f3n diferente que FDA)<\/p><\/td><td width=\"122\"><p>Igual que FDA<\/p><\/td><td width=\"125\"><p>N\u00fameros del 0 al 4 (incluye 0+, asignaci\u00f3n diferente que FDA\/EMA)<\/p><\/td><\/tr><tr><td width=\"121\"><p>Adhesion evaluation during induction phase (assigning scores)<\/p><\/td><td width=\"133\"><p>No requerido<\/p><\/td><td width=\"112\"><p>No requerido<\/p><\/td><td width=\"122\"><p>Not mentioned<\/p><\/td><td width=\"125\"><p>Required*<\/p><p>\u00a0<\/p><\/td><\/tr><tr><td width=\"121\"><p>An\u00e1lisis de sensibilizaci\u00f3n<\/p><\/td><td width=\"133\"><p>Solo estad\u00edsticas descriptivas<\/p><\/td><td width=\"112\"><p>Tabulaci\u00f3n de puntajes \u2265 2, sin estad\u00edsticas adicionales<\/p><p>.<\/p><\/td><td width=\"122\"><p>Promedio del test 80%-125% del RLD<\/p><\/td><td width=\"125\"><p>Grado de sensibilizaci\u00f3n: Test \u2264 RLD.<\/p><p>Tiempo de aparici\u00f3n: Test \u2265 RLD<\/p><\/td><\/tr><\/tbody><\/table><p>*Se permite el uso de cinta para reforzar los desprendimientos del parche.<\/p><p>\u00a0<\/p><h4><strong>Conclusiones<\/strong><\/h4><p>Aunque el objetivo sigue siendo el mismo, es decir, obtener un TDS intercambiable, los temas cl\u00ednicos requeridos por las gu\u00edas de agencias como Brasil y M\u00e9xico para aprobar un TDS gen\u00e9rico difieren de las de la EMA y la FDA.<\/p><p>Este escenario obliga a los patrocinadores a sintonizar estrechamente con la agencia correspondiente para acordar el conjunto esperado de estudios a incluir en la presentaci\u00f3n cl\u00ednica.<\/p><p>Avanzar hacia gu\u00edas m\u00e1s armonizadas y opiniones vinculantes por parte de evaluadores regulatorios permitir\u00eda revisar las presentaciones de parches gen\u00e9ricos en un entorno m\u00e1s razonable e igualitario.<\/p><p>En consecuencia, el desaf\u00edo radica en avanzar hacia gu\u00edas m\u00e1s armonizadas y definiciones vinculantes por parte de los evaluadores regulatorios, de manera que las presentaciones de parches gen\u00e9ricos puedan ser revisadas en un escenario m\u00e1s razonable y equilibrado.<\/p><p>\u00a0<\/p><h4><strong>Referencias<\/strong><\/h4><ul><li>Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs. Guidance for Industry, Draft, CDER\/FDA, Oct 2018.<\/li><li>Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms, EMA\/CHMP\/EWP\/280\/96 Rev1, 20-Nov-14. Last access: Nov 11, 2024.<\/li><\/ul><p>(<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf\">https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-pharmacokinetic-clinical-evaluation-modified-release-dosage-forms_en.pdf<\/a>)<\/p><ul><li>Product-Specific Guidances for Generic Drug Development, FDA. Last access: Nov 11, 2024. (<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/psg\/index.cfm?event=Home.Letter&amp;searchLetter=B#letterSearchBar\">https:\/\/www.accessdata.fda.gov\/scripts\/cder\/psg\/index.cfm?event=Home.Letter&amp;searchLetter=B#letterSearchBar<\/a>)<\/li><li>Di\u00e1rio Oficial da Uni\u00e3o, Instruc\u00e3o Normativa \u2013 IN N\u00ba 328, de 9 de Outubro de 2024. Last Access Nov 11, 2024: <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/instrucao-normativa-in-n-328-de-9-de-outubro-de-2024-589783953\">https:\/\/www.in.gov.br\/en\/web\/dou\/-\/instrucao-normativa-in-n-328-de-9-de-outubro-de-2024-589783953<\/a><\/li><li>Consulta P\u00fablica N\u00ba 760, 27\/Dezembro 2019, Public Consultative Proposal: Criteria for conduction of BA\/BE studies. Last access Nov 11, 2024: <a href=\"https:\/\/sindusfarma.org.br\/uploads\/files\/6c61-jessica-neto\/Boletins\/B_AR_n%C2%BA_004.2020%20-%20cp%20760%20-%20bioequivalencia%20e%20biodisponibilidade%20-%20Copy%201.pdf\">https:\/\/sindusfarma.org.br\/uploads\/files\/6c61-jessica-neto\/Boletins\/B_AR_n%C2%BA_004.2020%20-%20cp%20760%20-%20bioequivalencia%20e%20biodisponibilidade%20-%20Copy%201.pdf<\/a><\/li><li>Requirements for the registration of generic transdermal systems in Latin America. 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data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-afb4c3b elementor-widget elementor-widget-heading\" data-id=\"afb4c3b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/www.cuervoestudio.com.ar\/\">Copyright \u00a92021 Amarin Technologies \nTodos los derechos reservados - Desarrollo by <u>Cuervo estudio<\/u><\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-3ebecc6\" data-id=\"3ebecc6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Interchangeability guidances for transdermal systems need harmonization, as the next challenge to add uniformity and scientifical sense to the regulatory process.<\/p>\n<p>There are key differences among current guidances for interchangeability of transdermal systems, which could mean that a same clinical study is approved in one region and rejected in another one. The experience gathered till now seems to be enough to start considering a harmonization process.<\/p>","protected":false},"author":6,"featured_media":9943,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20,22],"tags":[],"class_list":["post-9942","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-challenges","category-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Transdermal Patch Manufacturing<\/title>\n<meta name=\"description\" content=\"The production of transdermal patches is a continuous and artisanal process that consists of 3 stages that reflect how delicate and specific is the production of this niche pharmaceutical form. 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