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 low and middle income countries.
Pharmacometrics is the science of developing and applying mathematical and statistical models to characterize, understand and predict a drug's pharmacokinetics, pharmacodynamics and biomaker-outcome behavior. By using pharmacometrics, researchers can model the characteristics of new drugs to simulate and predict their behavior, which can then enable more efficient development of new drugs and to improve use of existing drugs.
The Clinical Pharmacology and Pharmacometrics course comprises ten lessons which cover key aspects of clinical pharmacology and mathematical modelling that underpin the principles of pharmacometrics.
Participants conduct self-study on each lesson over 1 week, and then join a live tutorial at the end of the week during which a faculty member discusses the week’s materials and any exercises that were assigned. These tutorials are recorded for off-line viewing for those who might experience difficulties with internet connectivity. All participants are assigned into small groups under the mentorship of a member of the course faculty. The course faculty are subject matter experts - they update content, design the lesson assignments and tasks, participate in online discussions, summarize the weekly discussion threads, conduct or support the weekly live tutorials, mentor participants and prepare assessments on the performance of the participants in their tutor groups.
Please click here to access a detailed faculty profiles document. Online learning specialists from the Infectious Diseases Institute upload all content, guide all course participants on how to use the Virtual Learning Environment, maintain communication, document course processes and offer continuous technical support throughout the course. Please click here to access a detailed profiles document for the IDI e-learning team.
The lessons are as follows:
Lesson One
Clinical Pharmacology and Pharmacometrics:
This lesson presents the role of clinical pharmacology and pharmacometrics within clinical therapeutics and drug development. It starts with a review of the phases of clinical drug development and then describes some aspects of clinical trials focusing on clinical pharmacology studies.
Lesson Two
Absorption and Distribution:
This is the first of several lessons on pharmacokinetics. In this lesson, we introduce the processes of Absorption and Distribution.
Lesson Three
Elimination:
In this lesson, we describe the processes of drug elimination, in particular hepatic and renal elimination.
Lesson Four
Pharmacokinetics after single dose administration:
This lesson describes the pharmacokinetic profiles arising from IV bolus and extravascular single doses of a drug and the kinetics following constant rate intravenous infusion and multiple dosage regimens..
Lesson Five
Pharmacokinetics at steady state:
In Lesson 5, we will consider pharmacokinetic profiles at steady state.
Lesson Six
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 Seven
Mathematical implementation of pharmacokinetic Models:
This lesson takes you through the process of how to build and run models to describe the pharmacometrics of a drug, how to import and display data and simulate variability between individuals.
Lesson Eight
Mathematical implementation 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.
Lesson Nine
Fundamentals of Biostatistics:
This lesson looks at some basic statistics and the statistical tools required for effective data analysis.
Lesson Ten
Data Analysis and Regression:
This lesson provides a rationale for modelling and simulation in pharmacokinetics with a brief introduction to experimental design and maximum likelihood estimation. This lesson also 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 and History
The materials presented in this course have been extensively updated.
The original course 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.
In May 2019, a modification of the original same course was implemented and run for the first time in Africa by the Infectious Diseases Institute, College of Health Sciences, Makerere University. A report on this course is available here.
.Click here to access course content