{"id":2095,"date":"2022-04-05T14:45:00","date_gmt":"2022-04-05T14:45:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2022\/04\/05\/ich-e11a-draft-guideline-reaches-step-2-ich-process\/"},"modified":"2022-04-05T14:45:00","modified_gmt":"2022-04-05T14:45:00","slug":"ich-e11a-draft-guideline-reaches-step-2-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2022\/04\/05\/ich-e11a-draft-guideline-reaches-step-2-ich-process\/","title":{"rendered":"The ICH E11A Draft Guideline Reaches Step 2 of the ICH Process"},"content":{"rendered":"<p>The ICH E11A draft Guideline on Pediatric Extrapolation reached <em>Step 2<\/em> of the ICH process on 4 April 2022 and now enters the <a href=\"https:\/\/www.ich.org\/page\/public-consultations\">public consultation<\/a> period.<\/p>\n<p>This new ICH Guideline aims to promote international harmonisation of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and to improve the speed of access to new drugs for paediatric patients, while limiting the number of children required for enrolment in clinical trials.<\/p>\n<p>The E11A Guideline addresses and aligns terminology related to paediatric extrapolation; provides information on various approaches that can be utilised to support the use of paediatric extrapolation; discusses a systematic approach to use of paediatric extrapolation; and provides information on study designs and statistical analysis methods used when incorporating paediatric extrapolation into a paediatric drug development plan.<\/p>\n<p>Further information can be found on the <a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\">ICH E11A webpage<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH E11A draft Guideline on Pediatric Extrapolation reached Step 2 of the ICH process on 4 April 2022 and now enters the public consultation period.<\/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-2095","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\/2095","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=2095"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2095\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2095"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2095"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2095"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}