{"id":2051,"date":"2024-07-31T12:15:00","date_gmt":"2024-07-31T12:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2024\/07\/31\/ich-m13a-guideline-reaches-step-4-ich-process\/"},"modified":"2024-07-31T12:15:00","modified_gmt":"2024-07-31T12:15:00","slug":"ich-m13a-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2024\/07\/31\/ich-m13a-guideline-reaches-step-4-ich-process\/","title":{"rendered":"The ICH M13A Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH M13A Guideline and associated Q&amp;As on \u201cBioequivalence for Immediate-Release Solid Oral Dosage Forms\u201d reached <em>Step 4<\/em> of the ICH Process on 23 July 2024.<\/p>\n<p>This Guideline provides recommendations on conducting bioequivalence studies during both development and post approval phases for orally administered immediate-release solid oral dosage forms. The Q&amp;A document is intended to provide additional clarification and improve harmonisation of bioequivalence study design and data analysis.<\/p>\n<p>A <em>Step 4<\/em> Introductory Training Presentation has also been developed by the M13 EWG to summarise the content of the Guideline.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#13\">M13 page<\/a>, including the documents available for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M13A Guideline and associated Q&#038;As on \u201cBioequivalence for Immediate-Release Solid Oral Dosage Forms\u201d reached Step 4 of the ICH Process on 23 July 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-2051","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\/2051","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=2051"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2051\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2051"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2051"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2051"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}