ARTICLE | Regulation

Boosting Phase 0

April 18, 2005 7:00 AM UTC

FDA is explicitly endorsing the use of exploratory IND studies - so-called "Phase 0" studies - as a tool for discriminating between promising and troublesome drug candidates before investing in conventional Phase I trials or extensive preclinical testing.

The agency described the approach in draft guidance released last week. It emphasized that such studies can be approved based on less data than many sponsors think is required...