Enabling Dosing Flexibility in Early Phase Trials: An Integrated CMC and Manufacturing Strategy

Early phase clinical trials demand agility—especially when facing unpredictable PK/PD responses and potential adverse events. This session explores how tailored drug product formulations and robust stability programs empower clinical pharmacologists to adjust dosing in real time across trial arms in response to emerging data.

Learn how a well-structured IMPD, complete with defined dose ranges, shelf-life extension strategies, and a comprehensive stability program, supports adaptive dosing without compromising quality or regulatory compliance.

We’ll also discuss the critical role of on-demand manufacturing and GMP-compliant QC labs, where rapid release testing and Qualified Person (QP) oversight ensure agility and efficient progression through early clinical development.