Title of the workshop
Open source PBPK modelling with the OSPSuite (PK-Sim® & MoBi®) for MIDD
Sponsored by Pharmetheus and co-hosted by Pharmacometrics Africa, NPC
Workshop target audience
Scientists/ Pharmacometricians interested in physiologically based pharmacokinetic modeling (PBPK) modelling and interested in learning how to consider age dependency, predict drug-drug interactions (DDIs) and conduct population simulations in PK-Sim® & MoBi®.
The workshop will feature PBPK modelling with the Open Systems Pharmacology suite (OSPS) also known as PK-Sim® and MoBi®. The goals are:
• Getting an introduction to the open source PBPK software PK-Sim® & MoBi® and it’s use for small molecule for investigations in clinical drug development.
• Learn how to do age dependent extrapolation with PBPK models (very young or very old populations).
• Learn how to model complex DDIs.
The combination of use cases based on published examples and hands-on lectures will enable the participants to build their own PBPK projects and maximise their impact by integrating physiological and mechanistic knowledge with preclinical and clinical information.
While the workshop is aimed for beginners with PK-Sim® & MoBi®, many topics will be of interest even for advanced users.
Workshop Learning Objectives
During the workshop, the participants will have the opportunity to become familiar with the software in extensive hands-on sessions, which will follow after a brief introduction to the basic concepts of PBPK. The participants will have a chance to experience the stepwise PBPK model development and qualification. First, a base PBPK model is built and compared to observed data. Then the model is refined and through a question-based approach strategy further aspects for model extrapolation are explored. Next, the use of PBPK modelling for development of a DDI strategy is shown. We will teach you how to use and integrate pre-existing models and building blocks to create a whole-body PBPK model for complex DDIs (e.g. simultaneous induction and inhibition by a perpetrator) and optimise study protocols. Finally, a workflow is presented on how PBPK models can extrapolate beyond tested scenarios like scaling form adult populations to young, old and very old.
|08h30-09h00||Welcome and introduction|
|09h00-09h45||Concepts of PBPK and applications in drug development
- Introduction OSP suite and OSP community
|10h15-12h00||Setting up a PBPK model in PK-Sim
|13h00-14h30||Use of PBPK to support DDI strategy
|15h00-16h30||Use of PBPK to support pediatric or geriatric indications
Date and Duration
Monday, April 6th 2020: 8:30AM-5PM
Students: 25 $ / R400
Academia / Government: 125 $ / R1850
Commercial / Industry: 250 $ / R3750
Maximum Number Participants
Participants are expected to bring their laptops and have installed the OSPSuite packages
on their laptops (for instructions and software please click here).
For starters it is useful to check out the tutorial site (videos & hands-on) here