Resources

Books, regulatory guidance, professional resources, and further reading for Foundations of Pharmacometrics.

Tip

How to use this page: You do not need to read all of these resources before starting the course. Use this page as a reference library when you want deeper background, regulatory context, or additional examples.

Core Books

These books provide broad conceptual foundations for pharmacometrics, pharmacokinetics, pharmacodynamics, and model-informed drug development.

• 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.
• Rowland M, Tozer TN. Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications. Wolters Kluwer.
• Gibaldi M, Perrier D. Pharmacokinetics. Marcel Dekker.

Regulatory and Scientific Context

These guidance documents are useful for understanding how pharmacometric analyses support regulatory and drug-development decisions.

• FDA: Population Pharmacokinetics
• FDA: Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
• EMA: Clinical Pharmacology and Pharmacokinetics Guidelines
• EMA: Reporting the Results of Population Pharmacokinetic Analyses

Professional Organizations and Learning Communities

• International Society of Pharmacometrics
• ISoP Learning Center
• American College of Clinical Pharmacology
• American Society for Clinical Pharmacology and Therapeutics
• PAGE: Population Approach Group in Europe

Journals and Publication Venues

These journals commonly publish work related to pharmacometrics, clinical pharmacology, quantitative pharmacology, and model-informed drug development.

• CPT: Pharmacometrics & Systems Pharmacology
• Clinical Pharmacology & Therapeutics
• Journal of Pharmacokinetics and Pharmacodynamics
• The Journal of Clinical Pharmacology
• British Journal of Clinical Pharmacology
• AAPS Journal

Concepts Worth Revisiting

As you move through the course, return to this list when you want to connect individual lessons to the broader discipline.

• Exposure and response
• Variability and uncertainty
• Structural models and statistical models
• Model assumptions
• Model evaluation
• Simulation-based decision support
• Model-informed drug development
• Communication of quantitative evidence

Suggested Reading Path

If you are new to pharmacometrics, start with conceptual chapters in Bonate or Rowland and Tozer before moving to more specialized population modeling references.

If you already work in clinical pharmacology or drug development, focus on regulatory guidance, model-informed decision-making examples, and reporting standards.

Related AEAcademy PMx Courses

This course is intended to build conceptual foundations. Learners who want to move from concepts to implementation may continue with:

• Computational Foundations for Pharmacometrics (R Track)
• Noncompartmental Analysis (R Track)
• Population PK/PD Modeling and Simulation