{"id":1694,"date":"2026-10-06T12:40:51","date_gmt":"2026-10-06T12:40:51","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/s1c\/"},"modified":"2026-10-06T12:40:51","modified_gmt":"2026-10-06T12:40:51","slug":"s1c","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/s1c\/","title":{"rendered":"S1C \u2013 Dose Selection for Carcinogenicity Studies of Pharmaceuticals"},"content":{"rendered":"<p>This document addresses the criteria for the selection of the high dose to be used in carcinogenicity studies on new therapeutic agents to harmonise current practices and improve the design of studies. The Addendum on &#8220;Addition of a Limit Dose and Related Notes&#8221;, finalised in July 1997, has been incorporated into the core Guideline in November 2005, which was then renamed S1C(R1).<\/p>\n<p>The second revision has been approved by the ICH Steering Committee under <em>Step 4<\/em> in March 2008 (S1C(R2)). In the second revision, the pharmacokinetic endpoint of 25 is declared to be applicable also for pharmaceuticals with positive genotoxicity signals. This change has implications on &#8220;Refinement&#8221; (one of the 3R&#8217;s) in enhancing the welfare, e.g., reducing the pain or discomfort of the animals at the maximally tolerated dose (MTD).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This document addresses the criteria for the selection of the high dose to be used in carcinogenicity studies on new therapeutic agents to harmonise current practices and improve the design of studies. The Addendum on\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[19],"guideline_tag":[],"rd_phase":[],"class_list":["post-1694","guideline","type-guideline","status-publish","hentry","guideline_category-safety"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1694","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\/1694\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1694"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1694"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1694"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1694"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}