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.
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.
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.
Inhaltsangabe
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
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
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