Description
Simcyp Focused Workshop: Best Practice, June 3-7, 2024 | ONLINE
It is assumed that the participants are familiar with the
fundamentals of PBPK modeling and have hands-on experience.
The main aim of this focused workshop is to demonstrate the application of best practices in
developing PBPK models, and to indicate how to qualify and refine model performance. Various
case studies, including some real-life examples, will be presented.
The case studies will cover various elements of model development including DDIs, special
populations, transporters, and different formulations. Optimal in vitro and clinical data sets will
be discussed. Participants will learn how to choose the most suitable models and also investigate
the impact of various relevant assumptions on model performance. Requirements for regulatory
submissions will also be discussed.
It is assumed that the participants are familiar with the
fundamentals of PBPK modeling and have hands-on experience.
Live Online Courses
There are no refunds for Live Online courses. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
Objectives
Key aspects covered in this course:
• Hands-on experience using real-world case studies that have informed drug labels
• Quick overview of models within the Simcyp Simulator
• Model selection and how to pick the most suitable models
• What are the most appropriate in vitro data
• Leveraging clinical data to verify and refine PBPK model performance
• Application of special population models
• Application of sensitivity analysis in assessing the impact of uncertain parameters
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion - BP
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