esqLABS provides training to US FDA Scientists
August 2021: esqLABS provides training to US FDA Scientists on the use of the OSP Suite (PK-Sim® and MoBi®) for PBPK and QSP modeling and simulation
esqLABS has had the privilege to provide a detailed 3-day training to 15 Scientists from the U.S. Food and Drug Administration Division of Pharmacometrics, Office of Clinical Pharmacology in the Center for Drug Evaluation and Research on the use of the open-source software OSP Suite (PK-Sim® and MoBi®) for PBPK and QSP modeling and simulation.
The training consisted of a mix of lectures on the use of the modeling and simulation software within the respective application area and a detailed step-by-step demonstration of the software with hands-on use-cases from each application area.
The training was supplemented with detailed online material for self-study of the lecture material and documentation for step-by-step execution of the hands-on exercises, including video recordings of the lectures and software demonstrations.
The topics covered in the training were:
- Introduction to PBPK modeling and model qualification
- IVIVE and prediction of oral absorption with PK-Sim®
- Species extrapolation – predicting FIM from preclinical experiments
- PBPK for drug-drug interactions (DDI) with PK-Sim
- Age dependence of PK: Pediatrics/Geriatrics
- PBPK modeling of biologics & target-mediated drug disposition