{"id":32345,"date":"2021-05-21T05:19:50","date_gmt":"2021-05-21T05:19:50","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/opy751-clinical-trials-syllabus-for-biomedical-7th-sem-2019-regulation-anna-university-open-elective-ii\/"},"modified":"2021-05-21T05:19:50","modified_gmt":"2021-05-21T05:19:50","slug":"opy751-clinical-trials-syllabus-for-biomedical-7th-sem-2019-regulation-anna-university-open-elective-ii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/opy751-clinical-trials-syllabus-for-biomedical-7th-sem-2019-regulation-anna-university-open-elective-ii\/","title":{"rendered":"OPY751: Clinical Trials Syllabus for Biomedical 7th Sem 2019 Regulation Anna University (Open Elective-II)"},"content":{"rendered":"

Clinical Trials detailed syllabus for Biomedical Engineering (Biomedical) for 2019 regulation curriculum has been taken from the Anna Universities<\/a> official website and presented for the Biomedical students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below. <\/p>\n

For Biomedical Engineering 7th Sem scheme and its subjects, do visit Biomedical 7th Sem 2019 regulation scheme<\/a>. For Open Elective-II scheme and its subjects refer to Biomedical Open Elective-II syllabus scheme<\/a>. The detailed syllabus of clinical trials is as follows. <\/p>\n

Clinical Trials<\/title><\/p>\n<h4>Course Objective:<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Unit I<\/h4>\n<p align=\"justify\">\n<p><strong>Role of Clinical Trials in New Drug Development<\/strong><br \/>\n Drug Discovery, regulatory guidance and governance, pharmaceutical manufacturing, nonclinical research, clinical trials, post-marketing surveillance, ethical conduct during clinical trials.<\/p>\n<\/p>\n<h4>Unit II<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Unit III<\/h4>\n<p align=\"justify\">\n<p><strong>Alternate Trial Designs<\/strong><br \/>\n Crossover design, factorial design, equivalence trials, bioequivalence trials, non-inferiority trials, cluster randomized trials, multi-center trials.<\/p>\n<\/p>\n<h4>Unit IV<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Unit V<\/h4>\n<p align=\"justify\">\n<p><strong>Reporting of Trials<\/strong><br \/>\n Overview of reporting, trial profile, presenting baseline data, use of tables, figures, critical appraisal of report, meta-analysis.<\/p>\n<\/p>\n<h4>Course Outcome:<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Text Books:<\/h4>\n<p align=\"justify\">\n<ol>\n<li>Fundamentals of Clinical Trials, Lawrence M. Friedman, Springer Science and Business Media, 2010<\/li>\n<li>Textbook of Clinical Trials, David Machin, Simon Day, Sylvan Green, John Wiley and Sons, 2007<\/li>\n<li>Clinical Trials: A Practical Approach, Stuart J. Pocock, John Wiley and Sons, 17-Jul-2013<\/li>\n<\/ol>\n<h4>References:<\/h4>\n<p align=\"justify\">\n<ol>\n<li>Clinical trials, A practical guide to design, analysis and reporting. Duolao Wang and AmeetBakhai. Remedica. 2006.<\/li>\n<li>Introduction to statistics in pharmaceutical clinical trials. T.A. Durham and J Rick Turner. Pharmaceutical Press.<\/li>\n<li>Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, Tom Brody, Academic Press, 2016.<\/li>\n<\/ol>\n<p align=\"justify\">For detailed syllabus of all the other subjects of Biomedical Engineering 7th Sem, visit <a class=\"rank-math-link\" href=\"..\/category\/biomedical+7th-sem\">Biomedical 7th Sem subject syllabuses for 2019 regulation<\/a>. <\/p>\n<p align=\"justify\">For all Biomedical Engineering results, visit <a class=\"rank-math-link\" href=\"https:\/\/www.inspirenignite.com\/anna-university\/anna-university-results\/\">Anna University Biomedical all semester results<\/a> direct link. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Clinical Trials detailed syllabus for Biomedical Engineering (Biomedical) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the Biomedical students. For course code, […]<\/p>\n","protected":false},"author":2297,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[67],"tags":[],"class_list":["post-32345","post","type-post","status-publish","format-standard","hentry","category-bme"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/32345","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/users\/2297"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/comments?post=32345"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/32345\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=32345"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=32345"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=32345"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}