Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)

Rapid Fire Moderator(s)

• 

  Punit Marathe, PhD

  Vice President DMPK-TOX
  Agios Pharmaceuticals

Presentations:

• 3:00 PM – 3:15 PM ET

  A Novel Mechanistic Model for Drug Release from PLGA Implants
  

  Rapid Fire Speaker: Santosh Kumar Puttrevu, PhD – Certara UK (Simcyp Division)
• 3:15 PM – 3:30 PM ET

  Application of Modeling and Simulation in Long Acting Injectable Product Development
  

  Rapid Fire Speaker: Viera Lukacova, PhD – Simulations Plus, Inc.
• 3:30 PM – 3:45 PM ET

  Supporting Biowaivers with PBPK Virtual Bioequivalence: Importance of Within-Subject Variability
  

  Rapid Fire Speaker: Amin Rostami-Hodjegan, PharmD, PhD – Certara / University of Manchester
• 3:45 PM – 4:00 PM ET

  No Polysorbate 80 Effect on Human Intestinal Drug Permeability
  

  Rapid Fire Speaker: James E. Polli, Ph.D., FAAPS – University of Maryland School of Pharmacy