UCSF

ACDRS 2022 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose

Date: 
Monday, April 11, 2022 - 10:00 am to Friday, April 15, 2022 - 3:00 pm
Location: 
virtual/online

This is Session 3 of 6. Must register for the entire 2022 Course and not per session.

Topics

  • Choosing doses/exposures for first in human studies, and the role of pharmacokinetics-pharmacodynamics (PKPD) modeling and simulation
  • Biomarker strategy and qualification for efficacy and safety
  • Developing drugs from first in human dosing to understanding dose-exposure-response in patients – efficacy and safety
  • Regulatory perspective: Utilizing pharmacodynamic biomarkers in drug development
  • Quantitative principles for drug development decision-making
  • Dose-exposure ranging in early drug development
  • Exposure response and drug-drug interaction
  • Optimization of clinical trial design
  • Conundrums of the learning phase of drug development
  • Proof of concept
  • Data utilization for decision making at the end of the learning phase