{"id":2253,"date":"2016-10-19T18:00:00","date_gmt":"2016-10-19T18:00:00","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/2016\/10\/19\/new-ich-m10-guideline-development-bioanalytical-method-validation\/"},"modified":"2016-10-19T18:00:00","modified_gmt":"2016-10-19T18:00:00","slug":"new-ich-m10-guideline-development-bioanalytical-method-validation","status":"publish","type":"post","link":"https:\/\/dev.ich.org\/index.php\/2016\/10\/19\/new-ich-m10-guideline-development-bioanalytical-method-validation\/","title":{"rendered":"New ICH M10 Guideline in Development on Bioanalytical Method Validation"},"content":{"rendered":"<p>In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. This guideline will provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins.<\/p>\n<p>The M10 <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/ICH_M10_Concept_paper_final_7Oct2016.pdf\">Concept Paper<\/a> and <a href=\"https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/ICH_M10_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>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies.<\/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-2253","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\/2253","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=2253"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2253\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2253"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2253"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2253"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}