Overcoming Early Phase Development Challenges

Summary: In early phase of drug development, it is common to have limited amount of API due to the molecule synthetic route complexity and high manufacturing cost.  Finding the appropriate formulation is often challenging, labor intensive, and requires significant amount of API to test in a range of solvent vehicles.  As a result, many programs are suspended or slowed down before progressing into animal PK and toxicity studies, as well as first-in-human (FIH) studies.  

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