{"id":2155,"date":"2019-12-04T10:00:00","date_gmt":"2019-12-04T10:00:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2019\/12\/04\/ich-m9-and-qas-reach-step-4-ich-process\/"},"modified":"2019-12-04T10:00:00","modified_gmt":"2019-12-04T10:00:00","slug":"ich-m9-and-qas-reach-step-4-ich-process","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2019\/12\/04\/ich-m9-and-qas-reach-step-4-ich-process\/","title":{"rendered":"ICH M9 and Q&#038;As Reach Step 4 of the ICH Process"},"content":{"rendered":"<p>The ICH M9 Guideline and Q&amp;As on Biopharmaceutics Classification System (BCS)-based biowaivers reached <em>Step 4<\/em> of the ICH Process at the ICH meeting in Singapore on 20 November 2019.<\/p>\n<p>The ICH M9 Guideline and Q&amp;As provide recommendations to support the biopharmaceutics classification of medicinal products and to support the waiver of bioequivalence studies. This Guideline will reduce the costs and time of development and prevent unnecessary exposure of mostly healthy volunteers to medicinal products, as in vivo studies to prove the biopharmaceutical quality of the medicinal product would not be needed, and therefore, facilitate the patient\u2019s access to medicines or post-approval changes.<\/p>\n<p>The ICH M9 Guideline and Q&amp;As is available for download on the ICH website <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines#9\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ICH M9 Guideline and Q&#038;As on Biopharmaceutics Classification System (BCS)-based biowaivers reached Step 4 of the ICH Process.<\/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-2155","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\/2155","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=2155"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2155\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2155"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2155"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2155"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}