{"id":1729,"date":"2026-10-06T12:55:55","date_gmt":"2026-10-06T12:55:55","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/e15\/"},"modified":"2026-10-06T12:55:55","modified_gmt":"2026-10-06T12:55:55","slug":"e15","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/e15\/","title":{"rendered":"E15 \u2013 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories"},"content":{"rendered":"<p>The ICH Harmonised Guideline was finalised under <em>Step 4<\/em> in November 2007.<\/p>\n<p>This Guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories.<\/p>\n<p>The validation and qualification processes for genomic biomarkers, evidence for their intended use and acceptance criteria across ICH regions are outside of the scope of this guideline.<\/p>\n<p>As new scientific knowledge in the discipline of pharmacogenomics and pharmacogenetics emerges, the current guidance will be reviewed and expanded if appropriate.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH Harmonised Guideline was finalised under Step 4 in November 2007. This Guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers,\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[9],"guideline_tag":[],"rd_phase":[],"class_list":["post-1729","guideline","type-guideline","status-publish","hentry","guideline_category-efficacy"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1729","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\/1729\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1729"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1729"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1729"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1729"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}