Strategies For De-Risking Early-Phase Oral Small Molecule Drug Development

Many issues related to the performance characteristics of an active pharmaceutical ingredient (API) can be resolved by thoroughly examining various aspects of the molecule before making decisions about solubility enhancement and the delivery method. A team of experts—Lisa Caralli, Science and Technology Director, North America at Catalent Pharma Solutions, Stephen Tindal, Science and Technology Director, Europe at Catalent Pharma Solutions, and Katarina Vulic, Principal Scientist at Novartis Institutes for BioMedical Research—discusses solutions for early-phase drug product development. Topics included risk-reduction strategies, critical formulation considerations, and careful technology selection to stretch the often limited quantities of API available for early studies.