{"id":2251,"date":"2016-10-19T18:15:00","date_gmt":"2016-10-19T18:15:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2016\/10\/19\/new-ich-m9-guideline-development-biopharmaceutics-classification-system-bcs-based-biowaive\/"},"modified":"2016-10-19T18:15:00","modified_gmt":"2016-10-19T18:15:00","slug":"new-ich-m9-guideline-development-biopharmaceutics-classification-system-bcs-based-biowaive","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2016\/10\/19\/new-ich-m9-guideline-development-biopharmaceutics-classification-system-bcs-based-biowaive\/","title":{"rendered":"New ICH M9 Guideline in Development on Biopharmaceutics Classification System (BCS)-Based Biowaivers"},"content":{"rendered":"<p>In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies.<\/p>\n<p>The M9 <a href=\"https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Multidisciplinary\/M9\/ICH_M9_Concept_paper-final_7Oct2016.pdf\">Concept Paper<\/a> and <a href=\"https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Multidisciplinary\/M9\/ICH_M9_Bussiness_plan-final_7Oct2016.pdf\">Business Plan<\/a> are now available for download on the ICH website under <a href=\"https:\/\/www.ich.org\/page\/multidisciplinary-guidelines\">Multidisciplinary<\/a> page.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers.<\/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-2251","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\/2251","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=2251"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2251\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2251"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2251"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2251"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}