Description
July 13-17, 2026 | ONLINE
PBPK Model Analysis & Middle Out Approaches (PEPD)
Bridging top-down and bottom-up approaches for model informed drug development that meets regulatory requirements.
The workshop covers concepts and practical applications of integrating in vitro data and physiological knowledge with clinical observations for the purpose of estimating unknown/uncertain model parameters. Delegates will work through different sensitivity analysis tools for exploring the behavior of model outputs and determining key parameter sensitivities and will be introduced to the parameter estimation capabilities of the simulator for utilizing pre-clinical and clinical data in parameter refinement. The Simcyp-R package for running simulations and retrieving model outputs from within the R environment will be introduced and demonstrated. Delegates will explore various pharmacodynamic models that are available in the simulator.
The course is delivered as through a combination of lectures and tutor led interactive examples sessions.
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:
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The theoretical basis for combining bottom-up and top-down modelling and simulation that meets regulatory requirements
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Sensitivity Analysis
Workflow
Local methods: PK profiles, parametric scanning and population SA
Global methods including meta-modelling approaches
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Parameter estimation:
Step-by step guidance on data entry, fitting, and interpretation of results
Simultaneous fitting of parameters across several clinical trials species or over multiple species
Incorporation of individual level data through covariates
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Simcyp R:
Introduction to the Simcyp-R package and it’s capabilities
Scripts for key tasks
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Pharmacodynamics:
Models available
Use of preliminary clinical data to model and simulate various covariate effects (e.g., genotypic/phenotypic differences, effects of diseases such as renal impairment or cirrhosis)
PD at the relevant effect site (e.g., liver)
Options for user-defined PD models
Certificate
By completing/passing this course, you will attain the certificate PEPD 2025
User Accounts and Registrations
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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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