Education & Training
Physiologically Based
Pharmacokinetic (PBPK)
Modeling in Drug Development and Evaluation Workshop
April 6 – April 10, 2009
Learn how to use state-of-the-art modeling and simulation techniques:
- Assist in candidate selection
- Accelerate drug development
- Improve clinical trials design
Download course files
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Day 1
Introduction to Pharmacokinetic
Modeling
Simulation Languages
Demonstration of Berkeley Madonna
Regulatory Applications of Modeling and Simulations at FDA
The Value of PBPK in Drug Development Regulation and Evaluation
Exercise: A Two-Compartment Model of Digoxin
Day 2
Fundamentals of Clearance
Basic Concepts of PBPK Modeling
Exercise: One-Compartment Isolated Perfused Liver Model
Exercise: Protein Binding in Tissue and Blood
Exercise: A PBPK Model for Methotrexate
Day 3
PBPK Modeling of the Perinatal Period
Dealing with Uncertainty and Variability
Applications of PBPK Modeling in Preclinical Drug Development
Demonstration: Introduction to Modeling with Simcyp
Demonstration: Modeling of Drug-Drug Interactions
Day 4
Challenges in IVIVE Scaling of Microsomal Data
A Generic PBPK Model for Predictive DMPK
Best Practices for Predicting Human PK
PBPK and Pharmacodynamic Modeling with PK-Sim® and MoBi®
Day 5
Model Documentation and Evaluation
The Future PBPK/PD and Beyond
Biosimulation of Drug-Induced Liver Injury Using the Entelos Physiolab Platform
Exercise: Conducting a Safety Assessment for Retinoic Acid Using a PBPK Model
Exercise: Parameter Optimization and Sensitivity Analysis
Reference
Book Chapter