Weijun Li

Company: Exelixis

Job title: Senior Director, Biologics Analytical / CMC Lead

Seminars:

Panel Discussion: Drug Product Final Dosage Form/SKU Considerations vs. Clinical Dose Strategies From The Drug Product Development Perspective 2:00 pm

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?Read more

day: Day Two