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