A2: Introduction to physiologically-based pharmacokinetics
The module introduces the fundamental concepts of physiologically-based pharmacokinetic (PBPK) modeling. The overall theme of the module is to see PBPK modeling as a way to integrate prior knowledge on physiological processes, anatomical spaces and drug-specific properties into the modeling process and to generate questions (the more questions we ask, the better we are prepared), and test hypotheses.
|8:45 – 10:45||Introduction to PBPK modeling||Important ADME sub-processes, hepatic metabolisms and renal excretion||Lumping of PBPK models & its relation to classical compartmental models||Inter-individual|
variability, extrapolation to children & covariate modeling
|Introduction to PBPK modeling of monoclonal antibodies|
|30 min||Coffee break|
|11:15 - 13:00||Introduction to PBPK modeling (con't)||Hands-on||Hands-on||Hands-on||Hands-on|
|60 min||Lunch break|
|14:00 - 15:30||Tissue model and whole body PBPK models for small molecule drugs||A priori prediction of tissue partitioning||Guest lecture: Dr. Andreas Reichel, Bayer AG, Project meeting simulation||PK-Sim (Bayer AG): Introduction and hands-on||PBPK modeling in drug discovery, development and regulatory science|
|15 min||Coffee break|
|15:45 - 17:00||Hands-on||Hands-on (con't)||Project meeting simulation (con't)||Hands-on with PK-Sim (con't)|
|Evening||Social Event (joint event of A1+A2 module)|
- Prof. Wilhelm Huisinga; theoretical lectures
- PharMetrX PhD students (2nd/3rd year); hands-on exercises
- External contributions by our faculty members
Hard- and software
- Please bring your own laptop.
- MATLAB® (The MathWorks), please bring your own Matlab version if possible. Note that there exists a student version (incl. many toolboxes) for appr. 90 USD for PhD students.
- PK-Sim available for download at Open Systems Pharmacology Suite.
- W. Huisinga, Handouts of slides.
- W. Huisinga et al, Modeling inter-individual variability in physiologically-based pharmacokinetics and its link to mechanistic covariate modeling, CPT: Pharmacometrics & Systems Pharmacology, 1 (2012), e4 (incl. online supplement on parameter values and matlab files)
- M. Rowland et al, Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science, Annual Review of Pharmacology and Toxicology, 51 (2011), pp. 45-73
- Further references will be provided during the course.