Innovative Early Development Regulatory Approaches: expIND, expCTA, Microdosing
Clinical Pharmacology & Therapeutics December 19, 2007 WT Robinson 37 citations
The Food and Drug Administration (FDA) Critical Path Initiative as well as the European Medicines Agency Road Map to 2010 (ref. 2) call for opportunities for more efficient drug development. One of the initiatives that has emerged in this context is the elaboration through guidance of exploratory investigational new drugs (INDs)/clinical trial applications (CTAs). This article reviews the...