1st Edition
The Art and Science of Physiologically-Based Pharmacokinetics Modeling
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
1. From A Mathematical Model to a Technology, the 100 Years’ Evolution of PBPK
Xinyuan Zhang, Ping Zhao
2. Basic principles of PBPK modeling and simulation
Jennifer Dressman, Stefan Willmann, Rodrigo Cristofoletti
3. Oral Drug absorption in special populations: in vivo – in vitro – in silico evaluation
Maiara Montanha, Bart Hens
4. Physiologically based absorption models for complex formulations and dosage forms
Maxime Le Merdy, William W van Osdol, Viera Lukacova
5. Perfusion and permeability-limited distribution models
Helen Musther, Masoud Jamei, Iain Gardner and Armin Sepp
6. Modeling drug metabolism and excretion
Frederico Martins, Stephan Schaller and Luis David Jiménez Franco
7. Platform Qualification and Model verification
Mohamad Shebley
8. Applying PBPK modeling to predict drug-drug interactions
Thomas Wendl
9. Applying PBPK modeling to predict drug exposure in special populations
Mariana Guimarães, Mubtasim Murshed, Janny Pineiro Llanes, Rodrigo Cristofoletti and Nikoletta Fotaki
10. PBPK-based Virtual Bioequivalence Trials to Guide Drug Development
Amitava Mitra, Jim Mullin and Siri Kalyan Chirumamilla
11. Application of PBPK modeling to support clinical pharmacology regulatory decision-making
Xinyuan Zhang, Yuching Yang, Sreedharan Sabarinath, Ramana S Uppoor and Mehul Mehta
12. Physiologically based biopharmaceutics modeling (PBBM) in support of drug product specifications and biowaiver
Xavier Pepin, Fang Wu, Tycho Heimbach, Filippos Kesisoglou, Mandula Haritha, Rodrigo Cristofoletti and Sandra Suarez-Sharp
13. Integrating PBPK modeling and Organ-on-a-chip systems to inform drug development
Nicolò Milani, Neil Parrott, Yumi Yamamoto, Claire Simonneau, Nenad Manevski, Wen Li Kelly Chen, Martina Pigoni, and Stephen Fowler
Biography
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.
