Clinical Pharmacokinetics and Pharmacodynamics

7.5 credits

Syllabus, Master's level, 3FB225

A revised version of the syllabus is available.
Education cycle
Second cycle
Main field(s) of study and in-depth level
Drug Discovery and Development A1N, Pharmaceutical Sciences A1N
Grading system
Fail (U), Pass (G), Pass with distinction (VG)
Finalised by
The Educational Board of Pharmacy, 26 May 2016
Responsible department
Department of Pharmacy

General provisions

Substituting and corresponding to 3FB053 or 3FB625, Clinical pharmacokinetics, pharmacodynamics and advanced course C.

Entry requirements

For applicants within: - the programmes for Bachelor of Science in Pharmacy and Master of Science in Pharmacy, at least 60 credits within the area/subject is required, including Pharmacokinetics 7.5 credits, and knowledge corresponding to the programme courses in pharmacology and physiology. - the programme for Master of Science in Chemical Engineering, at least 60 credits within the programme is required, and courses corresponding to Pharmacokinetics 7.5 credits, Physiology 6 credits and Pharmacology 7.5 credits.

Admitted to the Master Programme in Drug Discovery and Development.

Acceptance to a single subject course requires a) basic qualification according to the higher education ordinance, and b) knowledge corresponding to 60 credits within the subject Pharmacy, Pharmaceutical science or within the subject Pharmaceutical bioscience, including Pharmacokinetics 7.5 credits, and c) knowledge corresponding to Physiology 6 credits and Pharmacology 7.5 credits.

Learning outcomes

On completion of the course, the student will be able to

• apply pharmacokinetic (PK) and pharmacodynamic (PD) information in clinical drug development.

• contribute at planning, design and analysis of clinical studies, from a PK and PD perspective.

• describe various types of variables that are used to measure and model drug effects.

• • Review different PD models that describe disease progression with and without simultaneous drug treatment

• Review PD models that describe the relationship between drug exposure and effect

• Review what a clinical trial simulation is and what information that is required to perform such a simulation

In this course, the student will train to

• give oral presentations in English.

• give constructive written feedback on other participants' oral presentations.

• analyse PK and PD data, both explorative analysis and mathematical based analysis.

• simulate pharmacokinetic and/or pharmacodynamic data.

• argue, discuss and decide.

• Write a report on a performed task in a format similar to a scholarly journal.


The course illustrates how PK and PD information can be used in clinical drug development with a focus on studies related to PK and/or PD. The course include presentation technique, application or data extraction from software for data analysis, simulation of clinical studies, presentation (e g Excel, Trial Simulator and Power Point) and models for relationships between drug exposure, effect and models for disease progression, PK and PD aspects on study design and clinical trial simulation.


The course assumes full-time studies. The main part of the work takes place in groups (up to 5 students per group).

The teaching consists of lectures, workshops and demonstrations/exercises with software. Each workshop is a larger assignment that is reported joint in groups or presented in writing individually.

Compulsory parts of the course:

The course introduction, certain in advance stated lectures and active participation in workshops.


During the course, continuous examinations that consist of an oral and/or written presentation are carried out.

For a Pass grade in the course is required, apart from approved examinations in each part (examination code), attendance at compulsory parts (examination code). Possibility to supplement failed compulsory parts can be given at the earliest at the next course date and only in case of a vacancy.

Re-examination is organised when necessary. Students who have failed the first examination are allowed five re-examinations.