The GastroPlus® RedIF Workshop is designed for modelers who would like to learn the fundamentals of physiologically based biopharmaceutics modeling and physiologically based pharmacokinetic modeling using GastroPlus.

Participants will become familiar with the latest versions of GastroPlus, including the main commands, tools, and workflows required to navigate the software and set up a PBPK model. Over five intensive sessions, you will learn how to:

• Set up a PBPK model using the latest GastroPlus modeling framework.
• Simulate the distribution and elimination of an active pharmaceutical ingredient following intravenous administration using a compartmental pharmacokinetic model.
• Define and evaluate the key parameters governing oral drug absorption.
• Integrate solubility and dissolution data into an absorption model.
• Develop PBBM–PBPK models for immediate-release and controlled-release drug products.
• Use fit-for-purpose models to conduct virtual bioequivalence assessments.
• Evaluate the potential effect of food on drug exposure.

More than a software tutorial, this workshop provides the scientific framework, practical skills, and modeling mindset required to support biopharmaceutics applications and regulatory decision-making.

You will learn not only how to use the latest GastroPlus features, but also why the different model-development steps should be performed in a particular sequence and how each step contributes to the overall credibility of a PBBM–PBPK modeling project.

Through hands-on exercises, live guidance from experienced instructors, and access to a complimentary temporary GastroPlus license, you will be able to work directly within the software, explore the presented workflows, and bring practical and immediately applicable modeling approaches back to your team.

Day 1
Monday, November 2nd | 8:30 AM – 5:30 PM CLST

Session 1: Getting Started with GastroPlus: Building a Solution PBPK Model

Session 2: From Solubility to Dissolution: Fundamentals of Oral Drug Absorption Modeling

Day 2
Tuesday, November 3rd | 8:30 AM – 5:30 PM CLST

Regulatory Applications of PBBM–PBPK Modeling for Generic Drug Development

• Scientific and Regulatory Considerations in the Development, Validation and Application of In Vitro In Vivo Correlations (IVIVCs) and In Vitro In Vivo Relationships (IVIVRs).
• The Role of Biopharmaceutics Risk Assessment and PBBM-Safe Space to Inform Drug Product Development and Regulatory Decision Making

Session 3: PBBM–PBPK Modeling for Immediate-Release Drug Products

Session 4: PBBM-Based IVIVC for Controlled-Release Drug Products

Session 5: Assessing Food Effects on Pharmacokinetics Using PBPK Modeling

Instructors:

• Maximo Pettarin, Scientist I
• Sandra Suárez-Sharp, Global Head of Regulatory Strategies