{"id":2360,"date":"2011-07-08T08:30:00","date_gmt":"2011-07-08T08:30:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2011\/07\/08\/ich-s6r1-step-4-m3r2-qas-step-4-and-quality-iwg-points-consider-published-ich-website\/"},"modified":"2011-07-08T08:30:00","modified_gmt":"2011-07-08T08:30:00","slug":"ich-s6r1-step-4-m3r2-qas-step-4-and-quality-iwg-points-consider-published-ich-website","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2011\/07\/08\/ich-s6r1-step-4-m3r2-qas-step-4-and-quality-iwg-points-consider-published-ich-website\/","title":{"rendered":"ICH S6(R1) Step 4, M3(R2) Q&#038;As Step 4 and Quality IWG Points to Consider Published on the ICH Website"},"content":{"rendered":"<p>The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline \u201cRevision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.\u201d The purpose of the addendum is to provide clarification of language in the original ICH S6 document regarding species selection, study design, immunogenicity, reproductive and developmental toxicity and carcinogenicity testing. The Addendum was integrated as Part II in the core S6 Guideline which was then renamed S6(R1). See the <a href=\"https:\/\/dev.ich.org\/wp-content\/uploads\/2026\/10\/S6_R1_Guideline.pdf\">S6(R1) Guideline<\/a><\/p>\n<p>The M3(R2) IWG, \u201cGuidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals\u201d finalized three sets of questions and answers at Step 4 which address limit dose, reversibility of toxicity, and metabolites. See the M3(R2) Q&amp;As<\/p>\n<p>The Quality Implementation Working Group (IWG) completed the \u2018Points to Consider\u2019 document on \u201cCriticality of Quality Attributes and Process Parameters,\u201d \u201cControl Strategy,\u201d and \u201cLevel of Documentation in Enhanced (QbD) Regulatory Submissions.\u201d This document will serve to provide supplementary information to the previously completed Q&amp;A\u2019s and training materials. See the <a href=\"https:\/\/dev.ich.org\/wp-content\/uploads\/2026\/10\/Quality_IWG_PtC_16_June_2011_0.pdf\">Quality PtC document<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline \u201cRevision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.\u201d<\/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-2360","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\/2360","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=2360"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2360\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2360"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2360"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}