{"id":1706,"date":"2026-10-06T12:48:52","date_gmt":"2026-10-06T12:48:52","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/s12\/"},"modified":"2026-10-06T12:48:52","modified_gmt":"2026-10-06T12:48:52","slug":"s12","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/s12\/","title":{"rendered":"S12 \u2013 Nonclinical Biodistribution Considerations for Gene Therapy Products"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2019.<\/p>\n<p>The ICH S12 Guideline reached <em>Step 4<\/em> of the ICH process on 14 March 2023.<\/p>\n<p>The ICH S12 Guideline:<\/p>\n<ul>\n<li>Provides harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products;<\/li>\n<li>Includes recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce\/refine\/replace) principles;<\/li>\n<li>Makes recommendations for the overall design of nonclinical BD assessments.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in June 2019. The ICH S12 Guideline reached Step 4 of the ICH process on 14 March 2023. The ICH S12 Guideline provides harmonised recommendations for the conduct of\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[19],"guideline_tag":[],"rd_phase":[],"class_list":["post-1706","guideline","type-guideline","status-publish","hentry","guideline_category-safety"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1706","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\/1706\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1706"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1706"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1706"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1706"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}