{"id":1745,"date":"2026-10-06T13:02:25","date_gmt":"2026-10-06T13:02:25","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m12\/"},"modified":"2026-10-06T13:02:25","modified_gmt":"2026-10-06T13:02:25","slug":"m12","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m12\/","title":{"rendered":"M12 \u2013 Drug Interaction Studies"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2018.<\/p>\n<p>The ICH M12 Guideline reached <em>Step 4<\/em> of the ICH process on 21 May 2024.<\/p>\n<p>The M12 Guideline:<\/p>\n<ul>\n<li>Is limited to pharmacokinetic interactions, with a focus on metabolic enzyme- and transporter-mediated interactions;<\/li>\n<li>Provides recommendations on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo (the terms \u2018clinical\u2019 and \u2018in vivo\u2019 are used interchangeably in this document), and on how to translate the results to appropriate treatment recommendations and also includes recommendations on how to address metabolite-mediated interactions;<\/li>\n<li>Provides recommendation for consistent approach to reduce uncertainty for the pharmaceutical industry to meet the requirements of multiple regulatory agencies and lead to more efficient utilization of resources.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2018. The ICH M12 Guideline reached Step 4 of the ICH process on 21 May 2024. The M12 Guideline is limited to pharmacokinetic interactions, with a focus on\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1745","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1745","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\/1745\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1745"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1745"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1745"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1745"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}