MIDD in Preclinical Drug Development​

Authors: Miller N
Conference: AAPS
Keywords: fih, FIHSimulator, first-in-human, PBPK model, pharmacokinetic predictions, preclinical verification
Division: PBPK

Description:

  • Provide a case for why you should focus on preclinical verification when using Physiologically Based Pharmacokinetic (PBPK) modeling for First-In-Human (F.I.H) pharmacokinetic predictions

Objectives

  • Appreciate that PBPK models are complex and combine systems physiology and drug specific input data
  • Understand that verification of PBPK models in preclinical R&D assesses whether the combination of physiology and drug specific input data works for a specific drug
  • Acknowledge that you should be realistic with your expectations and learn from poor predictions

By Neil A. Miller

Presented at American Association of Pharmaceutical Scientists (AAPS) PharmSci 360, October 17-20, 2021