Introduction to Physiologically-Based Modeling
PHA 6131 Introduction to Physiologically-Based Modeling

Credits

This is a 3-credit Course

Description

Introduction to Physiologically-Based Modeling is a 3-credit course that provides students and trainees with the theoretical concepts as well as hands-on applications in physiologically-based modeling and its use in drug development and regulatory evaluation with focus on physiologically-based pharmacokinetic (PBPK) modeling. Upon completion of this course, students will have gained a basic understanding of PBPK model components and parameters, key PBPK model building and verification steps, and the data needed to inform these models. They will also have completed hands-on training in different PBPK software platforms.

Upon completion of this course, student will be able to:

  1. Understand the role of physiologically-based models at different stages of drug development and regulatory evaluation with focus on physiologically-based pharmacokinetic (PBPK) models.
  2. Identify key PBPK model components and parameters
  3. Understand and apply PBPK model building and verification processes
  4. Identify the data needed to inform PBPK models
  5. Parametrize clearance, volume of distribution, and absorption processes using different in vitro and in vivo
    data sources
  6. Identify factors impacting clearance, volume of distribution, and oral drug absorption
  7. Understand the role of transporters and parametrize them in PBPK models
  8. Develop and verify models for major PBPK applications (i.e., absorption, drug-drug interactions, and special patients populations) in different software platforms
  9. Have a basic understanding of additional major PBPK applications (e.g., virtual bioequivalence and non- oral routes of absorption)
  10. Understand the setup of PBPK models for large molecules and how they differ from small molecules

Topics

Week Topic
Week 1 Introduction
Week 2 Physiologically-Based Modeling Approaches in Drug Development and Regulatory Evaluation
Week 3 PBPK Model Development and Verification
Week 4 Clearance
Week 5 Volume of Distribution
Week 6 Physiological Models for Oral Absorption
Week 7/8 Software Application 1: Absorption
Week 9/10 Software Application 2: DDI
Week 11/12 Software Application 3: Special Populations
Week 13/14 Additional Major PBPK Applications
Week 15 All teaching partners Large Molecules

Please see the downloadable syllabus for a full week/module topics breakdown.

Prerequisites

There are no prerequisites for this course.

Required Materials

Recommended Textbooks

  • Title: Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications
    • Authors:. H. Derendorf, S. Schmidt Wolters & Kluwer
    • 2020
    • ISBN number: 978-1496385048
  • Title: Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulation: Principles, Methods, and Applications in the Pharmaceutical Industry.
    • Author: S.A. Peters John Wiley & Sons, Inc. 2012
    • ISBN number: 978-0-470-48406-7

Additional reading assignments will be made available on the Canvas course site.