Course Resources
Documentation, regulatory guidance, books, and further reading for Population PK/PD Modeling and Simulation.
Tip
How to use this page: This course emphasizes applied population modeling workflows. Use these resources when you want official documentation, regulatory context, or deeper theory behind the modeling steps.
Core Books
- Ette EI, Williams PJ, editors. Pharmacometrics: The Science of Quantitative Pharmacology. Wiley.
- Bonate PL. Pharmacokinetic-Pharmacodynamic Modeling and Simulation. Springer.
- Gabrielsson J, Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Swedish Pharmaceutical Press.
- Mould DR, Upton RN. Basic concepts in population modeling, simulation, and model-based drug development.
- Lavielle M. Mixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools. Chapman and Hall/CRC.
Main R Package Documentation
Data, Visualization, and Workflow Packages
Regulatory Guidance
- FDA: Population Pharmacokinetics
- FDA: Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
- FDA: Clinical Pharmacology Considerations for Peptide Drug Products
- EMA: Reporting the Results of Population Pharmacokinetic Analyses
- EMA: Clinical Pharmacology and Pharmacokinetics Guidelines
Reporting and Good Practice
- Dykstra K, et al. Reporting guidelines for population pharmacokinetic analyses.
- ISoP Learning Center
- PAGE Abstract Archive
- CPT: Pharmacometrics & Systems Pharmacology
Key Concepts in This Course
- Population models
- Structural PK models
- Between-subject variability
- Residual unexplained variability
- Covariate modeling
- FOCEi estimation
- Objective function value
- Goodness-of-fit diagnostics
- Residual diagnostics
- Visual predictive checks
- Parameter precision
- PK/PD models
- Direct and delayed response models
- Individual and population simulation
- Dose scenario exploration
- Model-based decision support
Suggested Reading Path
If you are new to population modeling, first review the conceptual material in Foundations of Pharmacometrics and the core chapters in Bonate or Ette and Williams.
For implementation, start with nlmixr2 and rxode2 documentation, then focus on diagnostics, simulation, and reproducible reporting.
For regulatory or submission-oriented work, prioritize FDA and EMA guidance documents and examples of population PK/PD reporting.