Formulation design space with Translational Pharmaceutics®: Unlock flexibility in drug development

Using a formulation design space allows for a pre-defined range of drug product compositions to approved for clinical evaluation.

A design space is integrated within a single bioavailability study through iterative "make-and-test" cycles—a streamlined approach where we can evaluate clinical performance and optimize drug product formulation composition, all based on actual human data. 

This empowers your development team with real data to drive decision making and optimize formulation performance, dramatically accelerating timelines and increasing the probability of success.

A formulation design space is a trusted, innovative concept that we have been applying for nearly two decades as part of RapidFACT® programs, an application of the Translational Pharmaceutics® platform.

In traditional drug development, fixed drug product compositions are necessary before entering clinical testing. This rigidity leads to delays and inefficiencies when modifications are needed mid-trial. Translational Pharmaceutics® changes this by integrating drug product formulation and GMP manufacturing with clinical testing. 

In modified release drug development, in particular, a design space is a powerful tool that can be used with Translational Pharmaceutics®. Instead of assuming an in-vitro/in-vivo correlation, a design space allows critical-to-performance variables to be explored in one clinical study. 

Translational Pharmaceutics® along with the use of a design space can compress years of work and multiple clinical trials into a single, efficient development cycle.