Development
Clinical Pharmacology & Therapeutics (2008) doi:10.1038/sj.clpt.6100461
Innovative Early Development Regulatory Approaches: expIND, expCTA, Microdosing
WT Robinson1
1Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
Correspondence: WT Robinson, (William.robinson@novartis.com)
Received 25 September 2007; Accepted 30 October 2007; Published online 19 December 2007.
Abstract
The Food and Drug Administration (FDA) Critical Path Initiative1 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 history of these emerging guidances as well as the experience to date in their use by the industry.
