{"id":1746,"date":"2026-10-06T13:02:26","date_gmt":"2026-10-06T13:02:26","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m13a\/"},"modified":"2026-10-06T13:02:26","modified_gmt":"2026-10-06T13:02:26","slug":"m13a","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m13a\/","title":{"rendered":"M13A \u2013 Bioequivalence for Immediate-Release Solid Oral Dosage Forms"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in November 2019.<\/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. The ICH M13A Guideline is the first Guideline in the foreseen series to describe the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. How regulatory decisions may be made based on BE assessment is out of the scope of this guideline.<\/p>\n<p>Further information can be found in the M13 Concept Paper and Business Plan.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in November 2019. Part of the foreseen ICH M13 Guideline series (M13A-C), the ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE)\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1746","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1746","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\/1746\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1746"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1746"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1746"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1746"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}