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Innovative Early Development Regulatory Approaches: expIND, expCTA, Microdosing
Author(s) -
Robinson WT
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100461
Subject(s) - clinical pharmacology , drug development , context (archaeology) , food and drug administration , agency (philosophy) , regulatory agency , investigational drugs , pharmacology , clinical trial , medicine , business , drug , political science , public administration , sociology , geography , social science , archaeology
The Food and Drug Administration (FDA) Critical Path Initiative 1 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. Clinical Pharmacology & Therapeutics (2008) doi: 10.1038/sj.clpt.6100461