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

Moderator(s)

• 

  Tycho Heimbach, PhD

  Senior Principal Scientist/Director
  Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA, New Jersey

Presentations:

• 9:00 AM – 9:30 AM ET

  Prospective Prediction of Food Effect Using PBPK Modeling: Is the Science On Par with Expectations?
  

  Speaker: Ravi Shanker, PhD – Pfizer Worldwide R&D
• 9:30 AM – 10:00 AM ET

  Applying MIDD Paradigm to Inform Clinical Relevance of Dissolution Specifications
  

  Speaker: Mohamed-Eslam F. Mohamed, PhD, FCP – AbbVie
• 10:00 AM – 10:30 AM ET

  Applications of PBPK for Virtual BE Assessment of Dermal Products
  

  Speaker: Sebastian Polak, PhD – Certara UK
• 10:30 AM – 11:00 AM ET

  Physiologically-Based Pharmacokinetic Modeling to Support BE and Products Approval
  

  Government Speaker: Eleftheria Tsakalozou, PhD – US Food and Drug Adminstration