Workshop: PBPK modeling for FIH & DDI with OSP Suite
Physiologically-Based Pharmacokinetic (PBPK) modeling is a cornerstone of translational drug development, supporting First-in-Human (FIH) dose selection and Drug-Drug Interaction (DDI) risk assessment. This workshop offers hands-on training in PBPK modeling using the OSP Suite tools PK-Sim and MoBi (version 12), with practical applications to nonclinical and clinical scenarios.
Overview
This workshop provides an in-depth exploration of PBPK modeling for FIH and DDI applications. Participants will learn how to build, verify, and apply PBPK models across species, handle complex DDI mechanisms, and use simulations to inform study design. The course emphasizes practical skills in navigating PK-Sim and MoBi, incorporating in-vitro data, and evaluating model risk and regulatory applicability. Real-world case studies and guided exercises will reinforce core concepts.
Workshop goals
Enable participants to effectively develop, apply, and evaluate PBPK models for FIH and DDI decision-making using OSP Suite.
Workshop learning objectives
By the end of this workshop, participants will:
- Understand the core functionalities of PK-Sim and MoBi (version 12) for PBPK modeling.
- Build PBPK models in different species (e.g., Rat, Dog, Monkey).
- Establish in-vitro to in-vivo relationships within a PBPK framework.
- Access and apply reference compound files, enzyme/transporter data, and DDI mechanisms.
- Tackle complex DDI cases involving multiple enzymes, transporters, or endogenous biomarkers.
- Verify, qualify, and assess the applicability of PBPK models.
- Conduct simulations to inform FIH and DDI study designs.
- Evaluate model risk and formulate DDI recommendations for regulatory labeling.
Key topics covered
- Fundamentals of PBPK modeling with PK-Sim and MoBi
- Cross-species model development
- In-vitro to in-vivo extrapolation techniques
- Enzyme/transporter interaction modeling
- Complex DDI scenario handling with MoBi
- Model verification, qualification, and regulatory assessment
- Simulation strategies for FIH and DDI study design
- Risk assessment and labeling considerations
Target audience
This workshop is designed for scientists, pharmacometricians, and regulatory professionals involved in translational modeling and DDI evaluation. It is suitable for both newcomers to PBPK modeling and experienced users seeking to expand their skill set with the OSP Suite.
Workshop requirements
Participants must bring a laptop with PK-Sim and MoBi (version 12) installed. Basic knowledge of pharmacokinetics and drug metabolism is recommended; prior experience with PBPK modeling is helpful but not required.
Ready to discuss your workshop needs?
Email us at communication@pharmetheus.com