{"id":2074,"date":"2023-03-17T14:00:00","date_gmt":"2023-03-17T14:00:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2023\/03\/17\/ich-s12-guideline-reaches-step-4-ich-process\/"},"modified":"2023-03-17T14:00:00","modified_gmt":"2023-03-17T14:00:00","slug":"ich-s12-guideline-reaches-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2023\/03\/17\/ich-s12-guideline-reaches-step-4-ich-process\/","title":{"rendered":"The ICH S12 Guideline Reaches Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH S12 Guideline on <em>\u201cNonclinical Biodistribution Considerations for Gene Therapy Products\u201d<\/em> has reached <em>Step 4<\/em> of the ICH Process on 14 March 2023.<\/p>\n<p>This Guideline is intended to provide guidance on the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products that mediate their effect by the expression (transcription or translation) of transferred genetic materials, and harmonised recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce\/refine\/replace) principles.<\/p>\n<p>A <em>Step 4<\/em> Introductory Training Presentation has been developed by the S12 EWG to summarise the content of the Guideline.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/ich.org\/page\/safety-guidelines\">S12 page<\/a>, including the Guideline and the <em>Step 4<\/em> Introductory Training Presentation available for download.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH S12 Guideline on \u201cNonclinical Biodistribution Considerations for Gene Therapy Products\u201d has reached Step 4 of the ICH Process on 14 March 2023.<\/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-2074","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\/2074","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=2074"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2074\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}