{"id":1749,"date":"2026-10-06T13:02:27","date_gmt":"2026-10-06T13:02:27","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m15\/"},"modified":"2026-10-06T13:02:27","modified_gmt":"2026-10-06T13:02:27","slug":"m15","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m15\/","title":{"rendered":"M15 \u2013 General Principles for Model-Informed Drug Development"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in May 2020.<\/p>\n<p>Further to the ICH Management Committee&#8217;s endorsement of the M15 Concept Paper and Business Plan in November 2022, the M15 EWG was established to develop the ICH M15 Guideline to harmonise Model-Informed Drug Development General Principles (MIDD).<\/p>\n<p>The overarching guideline is expected to cover the general principles and good practices for the use of MIDD and will harmonise expectations regarding documentation standards, model development, data used in the analysis, model assessment, and its applications.<\/p>\n<p>Further information can be found in the M15 Concept Paper and Business Plan.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in May 2020. Further to the ICH Management Committee&#8217;s endorsement of the M15 Concept Paper and Business Plan in November 2022, the M15 EWG was established to develop the\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1749","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1749","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1749\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1749"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1749"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1749"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1749"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}