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 biomarker-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 twelve 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 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 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

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.

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.

The course was extensively revised and offered five (5) times in May 2019, January 2020 and May 2020, co-hosted by the Infectious Diseases Institute, Makerere University, Kampala, Uganda, and in November 2020 and April 2021 co-hosted by the Center for Research in Therapeutic Sciences (CREATES), Strathmore University, Nairobi, Kenya.

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