Bringing a new drug to market is a complex journey, often involving various dosage forms throughout clinical development. From initial discovery to final product, the needs can shift dramatically. For example, pediatric and oncology medicines often require a high degree of flexibility to accommodate adjustments in dose range, strength, and presentation.
While flexibility might not always be the primary focus, it's becoming increasingly important. Current regulatory trends emphasize the need to explore a wider range of doses, placing greater pressure on formulation development. Achieving these desired dose ranges within reasonable timelines, while minimizing costs and risks, requires a thoughtful and adaptable approach.
This executive summary, was realized after the webinar and it delves into the critical need for flexibility in clinical design, explores key regulatory considerations, and examines the practical aspects of developing dosage forms that can accommodate these evolving needs.