{"id":8856,"date":"2025-12-15T11:04:18","date_gmt":"2025-12-15T10:04:18","guid":{"rendered":"https:\/\/www.quinta.cz\/?p=8856"},"modified":"2025-12-15T11:04:18","modified_gmt":"2025-12-15T10:04:18","slug":"ivbe-for-locally-acting-drugs","status":"publish","type":"post","link":"https:\/\/www.quinta.cz\/cs\/2025\/12\/15\/ivbe-for-locally-acting-drugs\/","title":{"rendered":"IVBE for locally acting drugs: insights from Conscio Science Day in Munich"},"content":{"rendered":"<p data-start=\"331\" data-end=\"522\">For many development teams, the key question is no longer whether IVBE can work, but how early it should be integrated into the program to have a tangible impact on risk, timelines, and cost.<\/p>\n<p data-start=\"524\" data-end=\"696\">These questions and factors were at the core of a presentation by our Head of Biologics Department, Milan Mad\u011bra, delivered to our clients at Conscio Science Day in Munich.<\/p>\n<p data-start=\"698\" data-end=\"910\">In the PDF document below, we bring you a snapshot that outlines how we approach IVBE for locally acting drug products, from smart analytical design to robust data evaluation aligned with regulatory expectations.<\/p>\n<p data-start=\"912\" data-end=\"951\">By browsing the slides, you will see:<\/p>\n<ul data-start=\"952\" data-end=\"1216\">\n<li data-start=\"952\" data-end=\"1040\">\n<p data-start=\"954\" data-end=\"1040\">how IVBE can reshape your development roadmap in terms of both timelines and budget,<\/p>\n<\/li>\n<li data-start=\"1041\" data-end=\"1122\">\n<p data-start=\"1043\" data-end=\"1122\">how different in vitro tools can be integrated into a coherent IVBE strategy,<\/p>\n<\/li>\n<li data-start=\"1123\" data-end=\"1216\">\n<p data-start=\"1125\" data-end=\"1216\">why rigorous method development and validation are essential for a successful submission.<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1218\" data-end=\"1400\">All concepts are drawn from our day-to-day work at Quinta-Analytica (a <a href=\"http:\/\/www.consciogroup.com\" target=\"_blank\" rel=\"noopener\">Conscio Group<\/a> company) and are meant to serve as inspiration and a benchmark for your own development strategy.<\/p>\n<p style=\"text-align: center;\" data-start=\"1562\" data-end=\"1748\"><a href=\"https:\/\/www.quinta.cz\/wp-content\/uploads\/2025\/12\/IVBE-Analytical-Tools-for-Chemical-Research.pdf\"><strong><span style=\"color: #007672;\">Download the IVBE Analytical Tools for Chemical Research PDF<\/span><\/strong><\/a><\/p>\n<hr \/>\n<p style=\"text-align: center;\"><strong>Would you like to know more? <a href=\"https:\/\/www.quinta.cz\/contact\/\">Let us know<\/a>.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Can bioequivalence for locally acting drugs be demonstrated without a single subject in a clinical trial?<br \/>\nYes, if your in vitro bioequivalence (IVBE) toolkit is set up in the right way.<\/p>\n","protected":false},"author":5,"featured_media":8857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-8856","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorised"],"_links":{"self":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/8856","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/comments?post=8856"}],"version-history":[{"count":3,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/8856\/revisions"}],"predecessor-version":[{"id":8865,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/8856\/revisions\/8865"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media\/8857"}],"wp:attachment":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media?parent=8856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/categories?post=8856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/tags?post=8856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}