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Welcome & Keynote
Welcome from the OSP CC 25
Session I & II - Clinical Applications and Development
Human Intestinal Organoids and Potential Application for PBPK Modeling
Growing a Community-built Qualified OSP-Model Library
PK-SIM AND R FOR PBBM AND VBE - INTRODUCTION TO VIRTUAL BIOEQUIVALENCE WORKFLOWS
Bridging In Vitro Dissolution and In Vivo Pharmacokinetics: Application of a Novel PBBM Workflow to Vericiguat
Session III: Research and Development
Accelerating Drug Discovery: systematic application of PBPK/PD modelling supporting candidate selection
Insights on Predicting PK from Chemical Structure by Combining Machine Learning with Mechanistic Modeling
Integrating In Vitro and In Silico Approaches Enables Accurate Prediction of Drug-Induced Liver Injury
Session IV: Integrated PBPK-PD/QSP modeling
Tools and workflows for automated reporting of PBPK modeling with OSP
PBPK Modelling in Regulatory Submissions to the MHRA
Software Verification, Validation, and (CoU) Qualification of Open Source M&S Software for Regulatory Use in Translational Model-Informed Drug Development
Session V: Emerging areas
Building a Qualifiable MIDD Ecosystem with modular PBPK and QSP Models in OSP V12
PBPK-PD for siRNAs - An OSP implementation for Drug Disposition and Efficacy analyses
Session VI: Roadmap
OSP Software Release Roadmap
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