Skip to main content
ACoP 2024 Main banner
Final Program


Conference Program
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
ViewAttendees 1

Quantitative clinical pharmacology of antibody drug conjugate development: challenges and opportunities

Regulatory Experiences and Considerations for Model-Informed Approaches in Antibody-drug conjugates (ADCs) Drug Development

Wednesday, November 13, 2024
2:45 PM – 3:15 PM MST
Location: Canyon Ballroom

    Speaker(s)

  • Yangbing Li, PhD

    Senior Reviewer
    U.S. Food and Drug Administration

    Disclosure(s): No financial relationships to disclose

Disclosure(s):
Yangbing Li, PhD: No financial relationships to disclose
This presentation will provide a regulatory experience on pharmacometrics approaches to develop ADC products. The presentation will highlight factors that regulators consider when evaluating dosing strategies, dose- and exposure-response, benefit-risk profile for ADC products and provide relevant examples from regulatory submissions.