SimpliFIH® Solutions: Integrated Approach To First-in-Human for Bioavailability-Challenged Molecules

Oral administration of small molecules has become increasingly difficult because most new candidates demonstrate poor aqueous solubility. The bioavailability hurdle is made more challenging with the accelerated timelines, limited drug substance availability, and financial restrictions. This presentation discusses a proven model-based technology-selection methodology for poorly soluble molecules and an integrated formulation approach to minimize first-in-human (FIH) timelines. The role of API development and supply, solid state characterization, micro-dosing and encapsulation best practices for FIH studies is also be discussed along with representative case studies. To learn more, please watch our webinar.