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The Importance of De-risking Formulation and Dosing
Did you know 95% of drugs do not advance from preclinical to a successful Phase III?
This often happens because of challenges related to exposure, and those challenges can be a result of poor formulation development.
Once the formulation problems are uncovered in the clinic, it can be very difficult or impossible to correct the formulation. These problems can be avoided by conducting characterization and formulation studies early in the drug development process. Darren Matthews, BSc (Hons), PhD, Pharmaceutical Development Senior Research Leader, explains how in the following video.
We recommend bringing in formulation experts early in discovery projects. They can profile aspects of the compound, such as the crystallinity, stability, and solubility of novel molecules, and provide a developability assessment to support candidate nomination and maximize success in clinic.