Nijmegen, Netherlands

Introduction to Pharmacokinetic and Pharmacodynamic Analysis

when 5 July 2021 - 6 August 2021
language English
duration 5 weeks
credits 4 EC
fee EUR 600

The role of clinical pharmacology has been well-established in research as well as clinical practice. Its main function in drug development is to establish a dose that is both safe and effective. Furthermore clinical pharmacological research is used to extrapolate and validate dosing and safety of medicines in special populations and assessment of drug-drug interactions. In this course you will become acquainted with different techniques to describe and predict pharmacokinetics and pharmacodynamics and learn how to apply these translate research to practice.

The course exists of four weekly online modules (about 10 hours per module) that will be graded by means of an online exam. Subsequently, there will be a one-week hands-on training that requires physical attendance at Radboudumc.

Part one: Online Modules

This part will be offered online. Study from the comfort of your own home, and meet participants from all over the world, expanding your international network with no additional costs for hotels or flights. The part will consist of a combination of interactive live sessions, challenging discussions with other participants, group work and individual study. More information about our online summer school.

Module 1 - General concepts of pharmacokinetics

Pharmacokinetics relate to all processes that affect a drug inside the body. It is, in short, “what the body does to a drug”. In this course module, you will gain deeper understanding of all topics related to pharmacokinetics. Absorption, distribution, metabolism, and excretion of drugs will be discussed in detail. This module will also focus on the factors that may influence the pharmacokinetics of drugs, like food , drug-drug interactions and pregnancy.

Module 2 – Pharmacokinetic analyses

The second module will focus on how to analyse pharmacokinetic data by means of a non-compartmental analyses and the differences between compartmental vs non-compartmental analyses. Furthermore, the concepts of pharmacokinetic bioequivalency will be discussed. You will learn to interpret and critically evaluate pharmacokinetic studies and recognise their role in establishing dose recommendations in clinical guidelines.

Module 3 – Understanding pharmacokinetic/pharmacodynamic modelling and simulation

Pharmacodynamics relate to all processes in the body that are affected by a drug. It is, in short, “what the drug does to the body”. To be able to properly assess the efficacy/toxicity of a drug using pharmacokinetic data, it is essential to understand its relation for a specific drug. In this module, students will learn how exposure to a drug relates to how it affects the body. This module will also provide an introduction to the basic principles of population PK nonlinear mixed effects modelling (top-down) as well as physiologically based PK modelling (bottom-up). The aim is to familiarize with the different techniques and allow for interpretation and translation of these studies to practice.

Module 4 – Introduction to bioanalytical methods

The fifth module will focus on ensuring reliability of bioanalytical results. The technologies used for quantification of substances in biological matrices as well as the regulatory aspects with regards to bioanalytical assay development will be discussed. Various key components in bioanalysis will be discussed, such as sample preparation, sample stability, liquid chromatography, mass spectrometry, and uncertainty in measurements.

Part two: Hands-on training on Campus

This part of the course will take place on the campus of Radboud University, the greenest and most beautiful campus of the Netherlands. Both the city of Nijmegen and the university have an open and friendly atmosphere where students and staff feel safe and at home.

During this one week hands-on training at Radboudumc, you will gain experience with performing various pharmacokinetic analyses and designing your own research.

The week will start with an introduction to Radboudumc and a tour through the Radboudumc Pharmacy research facility, including the research lab. There will be several presentations from various leading researchers about i.e. pharmacokinetic research in special populations and the application of Therapeutic Drug Monitoring. You will get trained on performing non-compartmental PK analyses using WinNonlin, bioequivalence calculations, and Physiologically-Based PK simulations in SimCyp. Finally, you will work in groups on two assignments:

Design a pharmacokinetic study based to answer a preformulated research question
Perform a pharmacokinetic analysis based on fictional study results and present the results in the form of an oral presentation and an abstract.
No later than the 15th of June 2021 the Summer School organization and the university board will assess the COVID-19 situation and decide whether the hands-on training can take place as planned. If the situation does not allow for on-campus activities, this part of course will be cancelled and you will receive a full refund of the hands-on training fee.

Course leader

Rob ter Heine, Hospital Pharmacist/Clinical Pharmacologist
Pharmacy Department
Radboud University Medical Center

Tom Jacobs, Pharmacist/PhD Candidate
Pharmacy Department
Radboud University Medical Center

Target group

Master
PhD
Post-doc
Professional

This course is designed for PhD students, young researchers (from low- and middle-income countries) and Clinical Pharmacology fellows eager to increase their knowledge on PK/PD research. In addition, the course is available for (post)graduates and professionals working in hospitals, universities, NGOs, industry, governments and have a background in medical sciences (e.g. Pharmacy, Medicine, Biomedical Sciences, or Toxicology), who have an interest in conducting PK/PD research.

Course aim

After this course you are able to:

1. Demonstrate a comprehensive knowledge of all fields relevant to pharmacokinetic research, understand the role of bioanalytics in PK research, and interpret and critically evaluate PK studies;
2. Describe different types of PK/PD relations and understand to what extent pharmacokinetics parameters can predict the pharmacodynamic properties of a drug;
3. Design a pharmacokinetic study, perform a non-compartmental PK analysis, calculate bioequivalence, and understand how to use PK modelling approaches (bottom-up and top-down) to derive relevant pharmacokinetic parameters answering your research question;
4. Comprehend clinical implementation of pharmacokinetics and how this can contribute to drug dosing in various populations and assessment of drug-drug interactions.

Credits info

4 EC
Full course: 4 ECTS credits (workload 112 hours)
Online modules : 2 ECTS credits (workload 56 hours)

Fee info

EUR 600: For the full course (online modules and hands-on training on campus)
EUR 400: Online modules from 5-29 July 2021 are 200 EUR; the hands-on practice on campus from 2–6 August 2021 is 500 EUR

Scholarships

We offer several reduced fees

Register for this course
on course website