Formulation design space: a proven approach to maximize flexibility and outcomes within early clinical development.

Traditional formulation development studies involve expensive and time-consuming screening of prototypes in preclinical species to select 'lead' systems for evaluation in human clinical pharmacokinetic studies. A new paradigm, Translational Pharmaceutics, has emerged to integrate pharmaceutical development, manufacturing and clinical functions to address these restrictions. Rapid Formulation development and Clinical Testing (RapidFACT) is applied to exploit the benefits of Translational Pharmaceutics in the clinical screening and optimization of drug products. Benefits are maximized by the adapted utilization of the concept of 'formulation design space'. This article presents the experience of the application of design space within RapidFACT and is supported by data from over 200 formulations studied to date, including case studies on how the approach has been applied.