Advanced course

To acquire knowledge in basic population pharmacokinetics (and pharmacodynamics) modeling and underlying concepts including creation of data sets, model identification and evaluation, goodness of fit, and covariate analysis.

To use a model to simulate and compare different study designs.

To obtain basic knowledge and training in working with NONMEM software.

The application of pharmacokinetic/pharmacodynamic (PK/PD) principles is an integrated discipline in drug development. Pharmacometrics denotes quantitative aspects of the relationship between pharmacokinetics and drug effect(s), referred to as pharmacokinetic and pharmacodynamic modelling.The quantitative information derived from a mathematical model may help to optimise dosing regimens, provide a programme for drug treatment of the individual patient and predict the probable outcome of  future clinical studies or scientific experiments.

Population pharmacokinetics (and pharmacodynamics) plays an increasing role in the study of drug absorption and disposition in the population or subset of the population. Mathematical models are used to  address explicitly inter- and intra-individual variability, measurement errors, etc. Inter-individual variability includes factors such as age, gender, weight, liver- or renal function and disease status.  The use of these factors and modelling their relationship to specific pharmacokinetic (and/or pharmacodynamic) parameters characterises the population approach.

This course focuses on the modelling of pharmacokinetics and pharmacodynamics in a population setting taking into account sources of variability. A suitable pre-requisite for this course is “Pharmacometrics Part I: Modelling Pharmacokinetic and Pharmacodynamic Responses”, which will be offered next in 2013, or an equivalent introductory course on PK/PD modelling.

Lectures will include practical exercises to help students achieve the ultimate objective of the workshop: to become operational in population pharmacokinetic analysis. Exercises will be carried out using NONMEM.

Although many courses teach population pharmacokinetic approaches, this course offered by the University of Copenhagen is the only one in Denmark. The course should be seen as an introduction and invitation to population modelling concepts and applications (non-linear mixed effects modelling). NONMEM was selected as the software for this course as it is the gold standard within both academia and industry.

This is a one-week course.

At the end of the course, each participant must write an assignment showing that he or she has met the course objectives. The report could be a theoretical description of a scientific problem and a suggested (modelling) approach for solving it. The problem could be based on data from the participant’s own projects.

The course director will give a pass/fail grade to participants.

12 to 16 March 2012.

4 ECTS credit points (European Credit Transfer System).

101 working hours (20 for preparation, 35 for course, and 46 for report and evaluation).

Professor Per Hartvig Honoré, Department of Pharmacology and Pharmacotherapy at the Faculty of Pharmaceutical Sciences, University of Copenhagen.

Rikard Sandström, Ferring A/S
Frank Larsen, Lundbeck A/S
Kim Kristensen, AstraZeneca
Peter Thygesen, Novo Nordisk A/S

Total course fee: DKK 7,600 (including lunch),

of which operating costs: DKK 900.

1 February 2012.

20 participants.

While the course is primarily offered to PhD students, industry-based researchers in the field of pharmacokinetics-pharmacodynamics are also welcome.

Applicants enrolled in part-time master's programmes at the Faculty of Pharmaceutical Sciences, University of Copenhagen may also participate in the course.

It is assumed that participants have basic knowledge about classical modelling and simulation of drug absorption and distribution in the body, calculating pharmacokinetic parameters of a drug  and evaluating its effect(s), including the evaluation of study designs, general knowledge in the integration of pharmacokinetics and pharmacodynamics, and basic knowledge of statistics.

The course will be held in English.