{"id":1730,"date":"2026-10-06T12:55:55","date_gmt":"2026-10-06T12:55:55","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/e16\/"},"modified":"2026-10-06T12:55:55","modified_gmt":"2026-10-06T12:55:55","slug":"e16","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/e16\/","title":{"rendered":"E16 \u2013 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions"},"content":{"rendered":"<p>The ICH Harmonised Guideline was finalised under <em>Step 4<\/em> in August 2010. The Guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Harmonised Guideline was finalised under Step 4 in August 2010. The Guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers,\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[9],"guideline_tag":[],"rd_phase":[],"class_list":["post-1730","guideline","type-guideline","status-publish","hentry","guideline_category-efficacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1730","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\/1730\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1730"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1730"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1730"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}