| Time | Item |
|---|---|
| Innovative Approaches Session Chairs: Chara Litou, Certara and Bhagwat Prasad, Cincinnati Children’s Hospital | |
| 8:45 | Session Introduction |
| 8:55 | New Approach Methodologies and PBPK Integration Bhagwat Prasad, Cincinnati Children’s Hospital |
| 9:10 | A Review of Virtual Twins in PBPK Emily Mannix, Monash University |
| 9:25 | State-of-the-Art Cluster Gauss-Newton Method Redefines what PBPK Models can Address in Early Clinical Development Toshiaki Tsuchitani, Keio University |
| 9:40 | Predicting First-in-Human Pharmacokinetics: Comparative Evaluation of Standard PBPK, High-Throughput PBPK and Machine Learning Silvan Kaeser, Roche |
| 9:55 | Liquid Biopsy–Informed Physiologically Based Pharmacokinetic Modeling of Systemic Exposure to Tyrosine Kinase Inhibitors in Leukemia Amit Dahal, Rhode Island |
| 10:10 | Q&A |
| 10:30 | Refreshment Break & Poster Viewing |
| Oral Absorption Session Chairs: André Dallmann, Bayer and Nikoletta Fotaki, University of Bath | |
| 11:00 | Session Introduction |
| 11:10 | Establishing a physiologically based biopharmaceutics modelling and simulation framework to investigate the absorption process of poorly soluble drugs administered as amorphous solid dispersions (ASD) Julia Macente, J&J |
| 11:25 | Food effect prediction of a high permeability/low solubility drug formulated as an amorphous solid dispersion (ASD) using an Open Systems Pharmacology (OSP) PBBM approach Paul Vrenken, Pharmetheus |
| 11:40 | Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Humans: A Systematic Evaluation Harshad Jadhav, AstraZeneca |
| 11:55 | From Dissolution to PBPK: A Probabilistic, Literature-Driven Framework for Risk-Informed Bioequivalence Evaluation Jhennifer Rabelo, Universidade de São Paulo |
| 12:10 | Q&A |
| 12:30 | Closing Remarks |
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