Drug development costs are reported to exceed $1B USD, with daily revenues ranging from $1-3M. Shortening the time to market is critical to maximize return and secure a competitive advantage. Strategies that increase efficiencies and reduce cost are paramount.

For generic drug development in the OINDP space, striving toward a waiver of clinical endpoint testing is a route many are exploring. The FDA has shown commitment to this approach with its release of a product-specific guidance document highlighting alternative in vitro tests to demonstrate bioequivalence.

Innovator drug developers can also benefit from the data generated using these novel techniques to help guide key decisions early on regarding device selection, formulation development, and IVIVC.

In this webinar we will review the current landscape and discuss new tools and techniques that can be used to accelerate your development projects. We will demonstrate the importance of employing new in vitro analytical methods early on in your OINDP development projects in order to gain valuable insight and reach approval faster than you thought possible.