{"id":2081,"date":"2022-12-21T14:15:00","date_gmt":"2022-12-21T14:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2022\/12\/21\/ich-m13-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2022-12-21T14:15:00","modified_gmt":"2022-12-21T14:15:00","slug":"ich-m13-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2022\/12\/21\/ich-m13-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"ICH M13 Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached <em>Step 2<\/em> of the ICH process on 20 December 2022.<\/p>\n<p>Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules\/powders for oral suspension.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#13-0\">M13 page<\/a>, including the aforementioned draft guideline available for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 2 of the ICH process on 20 December 2022.<\/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-2081","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\/2081","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=2081"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2081\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2081"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2081"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2081"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}