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This state-of-the-art text describes the science behind the system and drug-dependent components of PBPK models, its applications in translational and regulatory science, e.g., guiding drug discovery and development, and supporting precision medicine initiatives. To incorporate state-of-the-art knowledge, each chapter is written by leaders in the field and illustrated by clear case studies. Connecting basic and applied science, this book explores the potential of PBPK modeling for improving therapeutics and is designed for a wide audience encompassing graduate students as well as biopharmaceutics scientists and clinical pharmacologists.
Features:
1. Provides a basic understanding of the physiologically-based pharmacokinetic modeling and its applications
2. Assists the reader in understanding product performance to allow for rapid product development and establish bioequivalence
3. Well-constructed content and added value of real examples
4. Illustrates how using available resources via modeling and simulation leads to a reduction in the costs related to drug development, which directly affects the costs to patients
List of contents
1. From A Mathematical Model to a Technology, the 100 Years' Evolution of PBPK
2. Basic principles of PBPK modeling and simulation
3. Oral Drug absorption in special populations: in vivo - in vitro - in silico evaluation
4. Physiologically based absorption models for complex formulations and dosage forms
5. Perfusion and permeability-limited distribution models
6. Modeling drug metabolism and excretion
7. Platform Qualification and Model verification
8. Applying PBPK modeling to predict drug-drug interactions
9. Applying PBPK modeling to predict drug exposure in special populations
10. PBPK-based Virtual Bioequivalence Trials to Guide Drug Development
11. Application of PBPK modeling to support clinical pharmacology regulatory decision-making
12. Physiologically based biopharmaceutics modeling (PBBM) in support of drug product specifications and biowaiver
13. Integrating PBPK modeling and Organ-on-a-chip systems to inform drug development
About the author
Rodrigo Cristofoletti, Ph.D., is Assistant Professor of Pharmacometrics and Systems Pharmacology and Associate Director of Centre for Pharmacometrics and Systems Pharmacology, University of Florida, USA.
Amin Rostami-Hodjegan, PhD, FCP, FAAPS, FJSSX, FBPS, is Professor of Systems Pharmacology and Director of Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester, UK and SVP of R&D, Chief Scientific Officer (CSO), Certara, Princeton, USA.
