Online Clinical Pharmacology & Pharmacometrics

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.

Online learning specialists from CREATES 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.

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: 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 the development of new drugs.In Lesson 5 we will consider the pharmacokinetic profiles arising from multiple dosing.

Lesson Six: Pharmacometrics at Steady state

Lesson 6 we will consider the pharmacokinetic profiles arising from multiple dosing.

Lesson Seven: Fundamentals of biostatistics

This lesson reviews basic statistics and the statistical tools required for effective data analysis

Lesson Eight: Introduction to Berkeley Madonna and IV models

This lesson will introduce you to the Berkeley Madonna (BM) software and take you through the process of how to build and run simple Pharmacokinetic (PK) Intravenous (IV) models, import and display data in BM.

Lesson Nine: Infusion and oral dosing and repeated dosing regimes in Berkeley Madonna

This lesson takes you through the process of how to build and run PK models of both infused and oral dosing with and without repeated dosing and learn how to simulate different dosing regimens and variabilities between individuals.

Lesson Ten: Pharmacokinetic and Pharmacodynamic Models in Berkeley Madonna

This lesson will provide an overview of how a pharmacodynamic (PD) effect is described mathematically and how it is included in a PK/PD model to relate drug concentrations to effect. The most common PD models used to describe an immediate or delayed effect of drug.

Lesson: Eleven: Independent Analysis and Bioequivalence Assessment

This lesson will address study design, regulatory, statistical and clinical pharmacology principles when analysing concentration – time data from pharmacokinetic studies e.g. during assessment of bioequivalence. Delegates will work with real clinical trial data, and gain insights into how formulations might be interchangeable

Lesson Twelve: 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

The materials presented in this course have been extensively updated. The original course was 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 course was implemented and run for the first time in Africa by the Infectious Diseases Institute (IDI), College of Health Sciences, Makerere University, Uganda. Two further courses were run by IDI, with improvements after each program with a view to wider dissemination of the course materials.