Proof of Concept

The FDA and other regulatory agencies have accepted data from EEC-type studies for onset of action and efficacy claims on labelling. EEC designs are also mentioned in the guidance for new chemical entities in allergy and bioequivalence studies for topical nasal products. Because these types of studies are not limited by the relatively short allergy seasons, proof of concept studies can be conducted outside of the traditional allergy seasons, allowing go/no go decisions to be made sooner, thereby considerably shortening drug development timelines.