This webinar will describe how formulation flexibility can be built into FIH studies achieving key clinical development milestones whilst still managing CMC time and cost investments.
The session will explain how pharmacy preparations, formulation development, GMP manufacturing and clinical testing can be tightly integrated to screen different drug product formats within adaptive FIH protocols so that early identification of patient-friendly dosage forms can be selected for a seamless transition into Phase II. In summary, the webinar will highlight how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.
Keynote Learning Objectives
- Learn about accelerating formulation development with integrated product development, manufacturing and clinical testing plan.
- Understand how it is possible to screen and evaluate multiple formulation technologies for poorly soluble molecules into a single clinical protocol.
- Hear how it is possible to bridge from 'fit-for-purpose' FIH formulations to 'patient ready' dosage forms without losing time in the development program.
John McDermott, Executive Drug Development Consultant, Quotient Sciences