Panel Discussion: Drug Product Final Dosage Form/SKU Considerations vs. Clinical Dose Strategies From The Drug Product Development Perspective
Time: 2:00 pm
day: Day Two
Details:
- How to configure drug product final dosage form for a wide range dose in clinical trials in phase 1?
- What triggers dosage form changes or addition in later phase development/commercialization? What are the typical challenges?
- How to set drug product specifications when the projected clinical dose range is wide?
