Transcription of CTD STRUCTURE: FROM IND TO NDA
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CTD STRUCTURE: FROM IND TO NDA
CTD STRUCTURE: FROM IND TO NDAM ichael G. Baker, & Principal | Samorn Biosciences___Susan Vintilla-Friedman, , Director, Development | Samorn BiosciencesComing together is a together is together is success. Henry FordAgenda+Typical Drug Development Timelines & Costs+CTD and its Role in Drug Development+CTD Origin and Purpose+CTD Structure+Evolution of the CTD from IND to NDA+Rest of World Awareness+Messaging: The Value of Storyboards+Agency Reviewer Perspective+ Authorship and QC+ Contributions of Each Functional Area+ Team Dynamics+ Timelines & Quality versus Expediency+ Tracking Progress+ Example CTD Structure for an NDA + Following NDA SubmissionDEVELOPMENT RESEARCHDISCOVERY RES / CLINICAL BASIC RESEARCHPOSTMARKETINGPHASE IPHASE IIPHASE III3 6 years6 7
While the CTD is intended to serve as a common global structure for drug development documentation, regional differences exist in requirements + In Europe, clinical trials are preceded by a Clinical Trial Application (CTA) + An Investigational Medicinal Product Dossier (IMPD) is required for approval of clinical
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