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 2 MARKET AUTHORIZATIONMARKET yearsTypical Drug Development Timeline5,000 10,000 compounds2505120 100 volunteers100 5000 volunteers> 5000 volunteers+ The Tufts Center for the Study of Drug Development (CSDD)
An Investigational Medicinal Product Dossier (IMPD) is required for approval of clinical trials by competent authorities in the European Union (EU)—the IMPD follows CTD structure + Paediatric investigation plan (PIP) may be required by European Medicines Agency (EMA) + Can be preceded by a request for Scientific Advice from EMA
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