Preclinical Tools for De-Risking and Accelerating Oral Drug Development
Summary: Success in drug development is a result of understanding risks, their implications, and making the right decisions to minimize them. Decisions made at an early stage influence the success at later stages. If not properly evaluated and managed, poor decisions can result in longer timelines and increased costs. This process should start when a lead clinical candidate is identified. However, most discovery programs are designed to evaluate and advance the compounds with the highest potency and specificity. This article outlines the preclinical studies to assess and manage developability risks of NMEs for oral drug products, including physiochemical evaluation, salt selection, and formulations selections for poorly soluble molecules.