Books: Preparation and Maintenance of the IND Application in eCTD Format

Posted 01 March 2009 | By

This book reviews Investigational New Drug (IND) application requirements and how to map them to the electronic Common Technical Document (eCTD) format. This is the first book to pull together the IND/CTD requirements, module-by-module; this format has been discussed at many conferences and in articles, but no guidance has ever been formalized by the US Food and Drug Administration (FDA).


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