Pharmacokinetics and PK/PD modelling
Provider: Faculty of Health and Medical Sciences

Activity no.: 3131-13-00-00 
Enrollment deadline: 01/02/2013
Date and time18.03.2013, at: 09:00 - 22.03.2013, at: 16:00
Regular seats12
Course fee5,640.00 kr.
LecturersPer Hartvig Honoré
ECTS credits4.50
Enrolment Handling/Course OrganiserPhD administration     E-mail address: phdkursus@sund.ku.dk
Aim and content
This course focuses on the modeling of pharmacokinetics and pharmacodynamics in a single subject setting. A suitable pre-requisite for this course is a profound knowledge of basic concepts within pharmacokinetics and pharmacodynamics. The extension of this course is "Pharmacometrics Part II: Population Modelling of PK and PD responses" which next time will be offered in 2014.

The application of pharmacokinetic/pharmacodynamic (PK/PD) principles is an integrated discipline in drug development. Pharmacometrics comprise quantitative aspects of the relationship between pharmacokinetics and drug effect(s). This is referred to as pharmacokinetic and pharmacodynamic modeling.The quantitative information in terms of a mathematical model may help in optimizing dosing regimens, drug treatment in the individual patient and prediction of future clinical studies or scientific experiments.

Pharmacokinetic (and pharmacodynamic) modelling is playing an increasing role in the study of drug absorption and disposition. Mathematical models are used to explicitly quantify relationships between time and concentrations or effects, including the potential relationship between effect and exposure.

This course will give the participants a basic introduction to the pharmacokinetic and PK/PD modelling of drugs and introduce practical modelling skills by the use of numerous hands-on sessions. The course will demand a high degree of hands-on activity by the students. All teaching will be based on the concept of: Show - Explain - Practice.

The different modelling topics will be introduced and the theoretical background explained before hands-on sessions on selected topics will be performed. The participants will be encouraged to bring their own data on to the course and use them during the course.

NONMEM is the software that is chosen for this course as it is the golden standard within both academia and industry. However, data from single individuals will be used. PK/PD modelling will be based on Emax models.

All participants are highly encouraged to bring own pharmacokinetic-pharmacodynamic data sets which they may work with during the course

The goals of this PhD course are that the participants:
- acquire knowledge in basic pharmacokinetic (and pharmacodynamic) modeling and underlying concepts including
- create data sets, become familiar with model identification and evaluation, goodness of fit, covariate analysis etc.
- are able to use a model to simulate and compare different study designs
- will obtain basic knowledge and training in working with the NONMEM software.
The lectures will involve practical exercises to achieve the ultimate objective of the workshop i.e. that participants become operational in pharmacokinetic analysis.
At the end of the course, an assignment showing that the participant has obtained the course objectives have to be written. This can be a theoretical description of a scientific problem and a suggested (modeling) approach to solve it. The problem could be based on data from the participants’ own projects.
A course diploma will be issued.
Prerequisites:
- The participants must have knowledge within primarily pharmacokinetics, ie. classical calculation of pharmacokinetic parameters.
- A general understanding on the integration of pharmacokinetics and pharmacodynamics.
- Basic knowledge in statistics.


Participants need to bring their own lap-top. Trial software (like NONMEM) will be provided for use during the course.


Dates:
March 2013 Week 12; 18 to 22 marts