Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe

Abstract

In contrast to a traditional Investigational New Drug Application (IND), under which typically only one molecule can be investigated, an Exploratory IND provides a sponsor the opportunity to conduct early-stage clinical studies on a series of closely related molecules under the same IND. This provision, therefore, enables sponsors to select the most promising molecule, from a series of closely related molecules, for further development using human subjects. This article provides an overview of the advantages and limitations of this approach to drug development.