{"id":2115,"date":"2021-05-10T13:45:00","date_gmt":"2021-05-10T13:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2021\/05\/10\/ich-s1br1-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2021-05-10T13:45:00","modified_gmt":"2021-05-10T13:45:00","slug":"ich-s1br1-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2021\/05\/10\/ich-s1br1-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"The ICH S1B(R1) Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH S1B(R1) Addendum to the Guideline on testing for carcinogenicity of pharmaceuticals reached <em>Step 2<\/em> of the ICH process on 10 May 2021 and now enters the public consultation period. This addendum is complementary to the S1 Guidelines (S1A, S1B and S1C(R2)) and, at <em>Step 4<\/em> of the ICH process, will be integrated with the S1B Guideline.<\/p>\n<p>This Addendum expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. Application of this integrative approach would reduce the use of animals in accordance with the 3Rs (reduce\/refine\/replace) principles, and shift resources to focus onto generating more scientific mechanism-based carcinogenicity assessments, while promoting safe and ethical development of new small molecule pharmaceuticals.<\/p>\n<p>A <em>Step 2<\/em> Informational Presentation is also made available by the S1B(R1) Expert Working Group.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/safety-guidelines\">S1B(R1) page<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH S1B(R1) draft Guideline reached Step 2 of the ICH process on 10 May 2021.<\/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-2115","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\/2115","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=2115"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2115\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2115"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2115"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2115"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}