Description
From Discovery to First-in-human (FIH) Using IVIVE-PBPK Modeling
In this focused workshop you will use the dynamic models within the Simcyp Discovery Simulator
to prioritise compounds for progress to the next stage of development using information
available in early drug discovery. You will use information on clearance, absorption, tissue
distribution and DDI liability to inform compound selection. Finally, from the originally
large database, only a few compounds will be selected for FIH and the simulation results
compared with available clinical data.
The case studies will cover various elements of model development including absorption, distribution and elimination.
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 have some familiarity 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
During the workshop you will be shown how to use a number of tools including:
• Static DDI tool
• SIVA toolkit
• Batch Processor
• Compound import
• Sensitivity analysis
• Parameter estimation
• Retrograde calculator
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion - FIH
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