{"id":634,"date":"2020-02-26T06:54:59","date_gmt":"2020-02-26T12:54:59","guid":{"rendered":"https:\/\/grupodesisa.mx\/blog\/?p=634"},"modified":"2020-02-26T07:01:43","modified_gmt":"2020-02-26T13:01:43","slug":"calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos","status":"publish","type":"post","link":"https:\/\/grupodesisa.mx\/blog\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\/","title":{"rendered":"C\u00e1lculos para periodo de rean\u00e1lisis o vida \u00fatil de f\u00e1rmacos y medicamentos"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"711\" src=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos-1024x711.png\" alt=\"\" class=\"wp-image-635\" srcset=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos-1024x711.png 1024w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos-300x208.png 300w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos-768x533.png 768w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos-1536x1066.png 1536w, https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos.png 2032w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>El objetivo de un estudio de estabilidad es conocer que tan estable se mantiene un medicamento en condiciones ambientales definidas, con base en el an\u00e1lisis de m\u00ednimo tres lotes del f\u00e1rmaco o medicamento. Por otro lado, tambi\u00e9n establecer con fundamento estad\u00edstico un per\u00edodo de rean\u00e1lisis o de vida \u00fatil, as\u00ed como conocer  las condiciones de almacenamiento indicadas en la etiqueta que aplicar\u00e1n a los lotes futuros fabricados y envasados en circunstancias similares.<\/p>\n\n\n\n<!--more-->\n\n\n\n<p>La gu\u00eda ICH Q1 indica que el an\u00e1lisis de regresi\u00f3n es un enfoque adecuado para el an\u00e1lisis cuantitativo de los datos de estabilidad  para determinar el periodo de rean\u00e1lisis o de vida \u00fatil y recomienda que se realice una prueba estad\u00edstica para conjuntar datos (Poolability).<\/p>\n\n\n\n<p>Antes de combinar los datos de varios lotes para estimar un per\u00edodo de rean\u00e1lisis o de vida \u00fatil, se debe realizar una prueba estad\u00edstica preliminar para determinar si las l\u00edneas de regresi\u00f3n de diferentes lotes tienen una pendiente com\u00fan y un intercepto com\u00fan al tiempo cero. El an\u00e1lisis de covarianza (ANCOVA) se puede utilizar para probar las diferencias en las pendientes y las intersecciones de las l\u00edneas de regresi\u00f3n entre los lotes del estudio de estabilidad.<\/p>\n\n\n\n<p>Un enfoque adecuado para calcular el periodo de rean\u00e1lisis o la vida \u00fatil es analizar un atributo cuantitativo (por ejemplo, valoraci\u00f3n y\/o productos de degradaci\u00f3n) mediante la determinaci\u00f3n del tiempo en el cual el l\u00edmite de confianza (alfa) de 95 por ciento cruza con el criterio de aceptaci\u00f3n propuesto o l\u00edmite de especificaci\u00f3n. <\/p>\n\n\n\n<p>Esta metodolog\u00eda es conocida como &#8220;Banda de Confianza&#8221; y est\u00e1 incluida en el software EESys\u00a9 V2 para la administraci\u00f3n, control y estad\u00edstica de los estudios de estabilidad. <\/p>\n\n\n\n<p>La misma gu\u00eda ICH Q1 indica que &#8220;se debe adoptar un m\u00e9todo sistem\u00e1tico en la presentaci\u00f3n y la evaluaci\u00f3n de la informaci\u00f3n de estabilidad&#8221;, as\u00ed que implementar un software como EESys\u00a9 V2 es un paso adelante del cumplimiento regulatorio que facilita el trabajo administrativo y estad\u00edstico.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El objetivo de un estudio de estabilidad es conocer que tan estable se mantiene un medicamento en condiciones ambientales definidas, con base en el an\u00e1lisis de m\u00ednimo tres lotes del f\u00e1rmaco o medicamento. Por otro lado, tambi\u00e9n establecer con fundamento estad\u00edstico un per\u00edodo de rean\u00e1lisis o de vida \u00fatil, as\u00ed como conocer las condiciones de [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[6],"class_list":["post-634","post","type-post","status-publish","format-standard","hentry","category-estudios-de-estabilidad-de-medicamentos","tag-estudios-de-estabilidad"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6.1 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>C\u00e1lculos para periodo de rean\u00e1lisis o vida \u00fatil de f\u00e1rmacos y medicamentos - Blog Desisa<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/grupodesisa.mx\/blog\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"C\u00e1lculos para periodo de rean\u00e1lisis o vida \u00fatil de f\u00e1rmacos y medicamentos\" \/>\n<meta property=\"og:description\" content=\"El objetivo de un estudio de estabilidad es conocer que tan estable se mantiene un medicamento en condiciones ambientales definidas, con base en el an\u00e1lisis de m\u00ednimo tres lotes del f\u00e1rmaco o medicamento. Por otro lado, tambi\u00e9n establecer con fundamento estad\u00edstico un per\u00edodo de rean\u00e1lisis o de vida \u00fatil, as\u00ed como conocer las condiciones de [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/grupodesisa.mx\/blog\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\/\" \/>\n<meta property=\"og:site_name\" content=\"Blog Desisa\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-26T12:54:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-02-26T13:01:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/grupodesisa.mx\/blog\/wp-content\/uploads\/2020\/02\/Banda-de-Confianza-calculo-caducidad-medicamentos-1024x711.png\" \/>\n<meta name=\"author\" content=\"desisa\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"desisa\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/\"},\"author\":{\"name\":\"desisa\",\"@id\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/#\\\/schema\\\/person\\\/bc40abe445f9259277f91bdbfeb85c2b\"},\"headline\":\"C\u00e1lculos para periodo de rean\u00e1lisis o vida \u00fatil de f\u00e1rmacos y medicamentos\",\"datePublished\":\"2020-02-26T12:54:59+00:00\",\"dateModified\":\"2020-02-26T13:01:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/\"},\"wordCount\":376,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/Banda-de-Confianza-calculo-caducidad-medicamentos-1024x711.png\",\"keywords\":[\"Estudios de Estabilidad\"],\"articleSection\":[\"Estudios de Estabilidad de Medicamentos\"],\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/\",\"url\":\"https:\\\/\\\/grupodesisa.mx\\\/blog\\\/calculos-para-periodo-de-reanalisis-o-vida-util-de-farmacos-y-medicamentos\\\/\",\"name\":\"C\u00e1lculos para periodo de rean\u00e1lisis o vida \u00fatil de f\u00e1rmacos y medicamentos - 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