Flexible Phase I Study Designs: Expediting Early Clinical Drug Development

Abstract

In this paper we provide an overview of some of the ways in which phase I packages can be tailored to the needs of the specific compound and conducted more efficiently using combination, flexible protocols. We outline the considerations that need to be made at the planning stage and how to make best use of emerging PK and safety data to enable informed decisions regarding study progression. A case study further illustrates how pharmacokinetics, safety, and tolerability of doses can be evaluated.