{"id":2053,"date":"2024-05-24T14:45:00","date_gmt":"2024-05-24T14:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2024\/05\/24\/ich-m12-guideline-reaches-step-4-ich-process\/"},"modified":"2024-05-24T14:45:00","modified_gmt":"2024-05-24T14:45:00","slug":"ich-m12-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2024\/05\/24\/ich-m12-guideline-reaches-step-4-ich-process\/","title":{"rendered":"The ICH M12 Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH M12 Guideline \u201cDrug Interaction Studies\u201d and \u201cDrug Interaction Studies Questions and Answers\u201d reached <em>Step 4<\/em> of the ICH Process on 21 May 2024.<\/p>\n<p>This Guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated <em>in vitro<\/em> and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. The supporting Questions and Answers is intended to provide additional clarification and improve harmonisation of drug interaction assessment.<\/p>\n<p>A <em>Step 4<\/em> Introductory Training Presentation has been developed by the M12 EWG to summarise the content of the Guideline.<\/p>\n<p>Further information can be found on <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#12\">the M12 page<\/a>, including the Guideline and <a href=\"https:\/\/www.ich.org\/page\/training-library\">the <em>Step 4<\/em> Introductory Training Presentation<\/a> available for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M12 Guideline \u201cDrug Interaction Studies\u201d and \u201cDrug Interaction Studies Questions and Answers\u201d reached Step 4 of the ICH Process on 21 May 2024.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-2053","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2053","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=2053"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2053\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2053"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2053"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2053"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}