Applying pharmacokinetic principles may maximize the goals of drug administration from the time first in man to approval. Quantitative aspects of the relation of pharmacokinetics to pharmacometrics, the drug effect, play a major role. Pharmacometrics focuses on the quantitative aspects of drug effects and kinetics in the body. The quantative information will optimize drug dosage, drug treatment in the individual patient and can be used to plan further research.  

Population pharmacokinetics plays an increased role in the study of drug absorption and disposition in the population or a subset of the population. Mathematical models are used to explicitly address inter- and intra-individual variability measurement, errors, etc. Factors such as age, weight, liver or renal function and disease  account for inter-individual variability. Identifying these factors and modelling their relationship to specific pharmacokinetic parameters is an important component of population approaches.

The purpose of this PhD course is:

• to provide participants with knowledge about population pharmacokinetics and underlying concepts
• to establish rules for the rational development of a population pharmacokinetic model
• to predict dose using a priori and posteriori methods
• to handle a data set used in population kinetic calculations
• to provide practical training

Lectures will include practical exercises to promote the ultimate objective of the workshop: for participants to become operational in population pharmacokinetic analysis. Exercises will be carried out using NONMEM, which is the gold standard software for population modelling.

Prerequisite:

• basic knowledge of and experience with classic pharmacokinetic modelling
• basic knowledge of statistics.

You need to bring your own laptop. Software (like NONMEM) will be provided for the duration of the course.

There will be an exam based on data from participants at the end of the workshop. Participants will receive a diploma. All participants are required to write a max. 10-page report on a tentative pharmacokinetic-pharmacodynamic study setting out its merits as well as methods of validation for accuracy and robustness.

The course leader will grade participants on a pass/fail basis.

22 to 26 March 2010.

4 ECTS (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, Faculty of Pharmaceutical Sciences, University of Copenhagen.

Total course fee: DKK 8,100 (including lunch),

of which operating costs: DKK 1,200.

1 February 2010.

20 participants.

The course is primarily offered to PhD students but also to industry-based researchers in the field of pharmacokinetics-pharmacodynamics.

Applicants enrolled in part-time MIND master's programme at the Faculty of Pharmaceutical Sciences, University of Copenhagen may participate in the course. They need knowledge corresponding to elective course B-371.