This online course is part of a set of training activities offered by Pharmacometrics Africa to support the development of pharmacometric competency and expertise in Africa and the developing world. These materials are based on a course that was previously developed and made available as open-access under creative commons principles, from Hibernia College, Dublin using grant funds from Novartis Pharma AG and the Bill & Melinda Gates Foundation.
Pharmacometrics is a scientific and mathematical approach to drug development that uses model-based drug development (MBDD) to quantify the interactions between drugs and patients. By using pharmacometrics, researchers can model the characteristics of new drugs to simulate and predict their behaviour, which can then enable more efficient and optimal drug development.
This course comprises ten lessons which cover key aspects of clinical pharmacology and mathematical modelling that underpin the principles of pharmacometrics.
The lessons are as follows:
Lesson One
Clinical Pharmacology and the Role of Pharmacometrics:
This lesson presents an overview of the components of pharmacometric modelling and its potential for the pharmaceutical industry.
Lesson Two
Absorption and Distribution:
This lesson reviews the processes by which drugs are absorbed by- and distributed around the body.
Lesson Three
Metabolism and Elimination:
This lesson explores processes of metabolism and excretion, and the roles they play in relation to pharmacological and toxicological responses to drugs.
Lesson Four
Pharmacokinetics:
This lesson examines the mathematical relationships used to describe pharmacokinetics and applications in therapeutic drug monitoring.
Lesson Five
Pharmacology:
This 2-part lesson reviews the basic principles of drug action via ligand receptor stimulus and response, and then expands on these concepts to dose (or concentration) response relative to clinical trial data collected during development of new drugs.
Lesson Six
Mathematical implementation of pharmacokinetic models
This lesson takes you through the process of how to build and run models for the pharmacometrics of a drug, how to import and display data and simulate variability between individuals.
Lesson Seven
Mathematical Description of Pharmacokinetic and Pharmacodynamic Models
This lesson will provide an overview of the mathematical implementation of models in pharmacology. Firstly, it will give a brief overview of modelling in general and will then focus on compartmental models. It will introduce differential equations and describe the most commonly used pharmacokinetic (PK) and pharmacodynamic (PD) models. Finally, it will provide a brief overview of physiologically based PK (PDPK) modelling.
Lession Eight
Fundamentals of Biostatistics:
This lesson looks at some basic statistics and the statistical tools required for effective data analysis.
Lesson Nine
Data Analysis and Regression (Part 1):
This lesson provides a rationale for modelling and simulation in pharmacokinetics with a brief introduction to experimental design and maximum likelihood estimation.
Lesson Ten
Data Analysis and Regression (Part 2):
This lesson provides a number of modelling exercises for you to investigate. In addition, the lesson provides an introduction to the importance of good experimental design.
Acknowledgements
The materials presented in this course are based on a course that was previously developed and made available under creative commons principles, as open-access from Hibernia College, Dublin using grant funds from Novartis Pharma AG and the Bill & Melinda Gates Foundation. Hibernia College presented this course in 2014. A course with similar training content was presented by Karolinska Institutet, Sweden in 2015.