Credits
This is a 3-credit hour course.
Description
- Provides a comprehensive overview of Quantitative Systems Pharmacology (QSP) modeling and its applications across the drug development process. This course mimics a real-world QSP project by integrating theory, practice, and the experience of working in multidisciplinary groups. Students will gain a foundational understanding of QSP principles, develop and evaluate models based on disease pathophysiology and drug mechanisms of action, and explore QSP’s role in R&D. Emphasis is placed on practical model development, literature analysis, regulatory considerations, and effective communication of results to multidisciplinary teams, fostering decision-making and problem-solving skills for real-world applications.
- By the end of the course, the students will be able to:
- Define what QSP is, explain key features and basic principles, and compare it with other methodologies such as PopPK/PD, PBPK, etc
- Demonstrate proficiency in applying various types of equations to describe physiological processes
- Analyze and compare possible model options, select an optimal one, and explain the criteria of choice
- Demonstrate practical proficiency in developing QSP models using software tools and identifying necessary data for parameter estimation
- Appraise model quality, sensitivity analysis, and validation results
- Build decision-making skills and the ability to draw meaningful conclusions from the modeling exercise
Pre-Requisites
PHA6125 Introduction to Quantitative Pharmacology
Topics
| Week | Module/Topic |
|---|---|
| Week 1 | Introduction to Quantitative Systems Pharmacology |
| Week 2 | Mathematical Representations of Biological Processes |
| Week 3 | Insights from the Field: Case Studies with Industry Experts |
| Week 4 | Building Knowledge: Literature Review and Database Creation |
| Week 5 | From Concept to Implementation: Model Development Workflow |
| Week 6 | Identifying Physiologically Based Parameters for Model |
| Week 7 | Software Tools for QSP Modeling |
| Week 8 | Parameter Estimation and Model Evaluation |
| Week 9 | Sensitivity Analysis and Model Validation |
| Week 10 | Regulatory Considerations in QSP |
| Week 11 | Effective Communication with Multidisciplinary Teams |
| Week 12 | Exam: Final Group Projects submission |
| Week 13 | Peer Review Essentials: Giving and Receiving Constructive Feedback |
| Week 14 | Break |
| Week 15 | Group Project |
Course Materials and Technology
There is no required textbook for this course.
Software:
This course utilizes open-source software, ensuring no additional cost to students
- R & R Studio:
- https://cran.r-project.org/bin/windows/base/
- https://www.rstudio.com/products/rstudio/download/#download
Recommended Materials
Title: Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications
Authors: Hartmut Derendorf, Stephan Schmidt
Publisher: Wolters Kluwer Health; 5th edition (July 11, 2019)
ISBN-13: 978-1496385048 | ISBN-10: 1496385047
Title: Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications
Authors: Johan Gabrielsson, Daniel Weiner
Publisher: Swedish Pharmaceutical Press; 4th edition (July 4, 2007)
ISBN-13: 978-9197651004 | ISBN-10: 9197651001
Title: Pharmacokinetic-Pharmacodynamic Modeling and Simulation
Author: Peter L. Bonate
Publisher: Springer; 2nd ed. 2011 edition (July 1, 2011)
ISBN-13: 978-1441994844 | ISBN-10: 144199484X
Journal articles, class notes developed by the instructor, or other required reading/resources will be provided to students through the Canvas course website.
For assistance with Canvas or other course technology, please contact: UF Distance Education Support Services – ahc-dess@ufl.edu