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Books: New Drug Approval Process, Fourth Edition, Accelerating Global Registrations
Posted 01 April 2008 | By
One of my goals for 2007 was to find a text that would help me teach global regulatory affairs (regulatory requirements outside the US) as an instructor for the Regulatory Affairs Certificate program at the University of California, Santa Cruz extension. At first, I thought this was the text I sought. This book turned out to be a guidebook to drug development, like an abbreviated and condensed version of Bert Spilker's Guide to Clinical Trials. It does provide a global perspective on drug development and the registration process from preclinical to the filing of the New Drug Application (NDA) and all the bits and pieces that need to be taken into consideration, not just from a regulatory perspective.