{"id":2087,"date":"2022-08-15T11:45:00","date_gmt":"2022-08-15T11:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2022\/08\/15\/addendum-s1b-reaches-step-4-ich-process\/"},"modified":"2022-08-15T11:45:00","modified_gmt":"2022-08-15T11:45:00","slug":"addendum-s1b-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2022\/08\/15\/addendum-s1b-reaches-step-4-ich-process\/","title":{"rendered":"Addendum to S1B Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The Addendum to the ICH S1B Guideline has reached <em>Step 4<\/em> of the ICH process on 4 August 2022, being integrated with the original guideline and published as ICH S1B(R1) Testing for Carcinogenicity of Pharmaceuticals.<\/p>\n<p>The new Addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline.<\/p>\n<p>Application of this integrative approach reduces the use of animals in accordance with the 3R (reduce\/refine\/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments, while continuing to promote safe and ethical development of new pharmaceuticals.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/ich.org\/page\/safety-guidelines#1-2\">S1B(R1) page<\/a>, including the <em>Step 4<\/em> Informational Presentation for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Addendum to the ICH S1B Guideline has reached Step 4 of the ICH process on 4 August 2022, being integrated with the original guideline and published as ICH S1B(R1) Testing for Carcinogenicity of Pharmaceuticals.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-2087","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2087","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=2087"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2087\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2087"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2087"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2087"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}