Description
March 17-21, 2025 | ONLINE
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
User Accounts and Registrations
The email address used for your user login must be an individual account. No sharing of user accounts between multiple individuals is allowed. Each user account (and any associated course registrations) is for a specific person, and cannot be transferred to a different individual once the course has started.
Course Materials
As a course registrant, you may view and read all materials related to your registered courses. However, you may not share, communicate, publish, copy or in any manner distribute to other parties the course materials, reference material provided, assignment solutions, quiz questions, exam questions, links or any other materials.
Cancellation Policy
Live Online Courses
There are no refunds for Live Online courses for cancellation or non-attendance by the participant. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
e-Learning and Certifications
There are no refunds for e-Learning courses or certifications. Course expiration dates can be found on your Dashboard.
Electronic Communication
We will send you email notifications regarding your training courses, including enrollment confirmations, purchase confirmations, and reminders of upcoming sessions. We will also send email for general announcements about the site. You can opt out of these emails if you wish (located in your profile).
Details
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