Entry requirements

150 credits, including 120 credits in biomedicine, biology, pharmaceutical sciences, chemistry and/or natural sciences/technology. Previous studies should include 5 credits of pharmacokinetics and 7.5 credits of pharmacology.

Proficiency in English equivalent to the Swedish upper secondary course English 6.

Learning outcomes

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

* Analyse 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 and interpret various types of variables and parameters that are used to measure and model drug effects.

* Explain and apply PD models that describe disease progression and 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.

* Illustrate how models can contribute to adjustment of drug dosing at an individual level

* Orally present and discuss results, in proper English, and give constructive feedback to other participants

* Summarize scientific publications and a performed task in writing, in a format similar to a scientific report.

* Work in an assigned team and reflect on and discuss group dynamics.

Content

The course illustrates how PK and PD information can be used in clinical drug development with a focus on studies relatedto PK and/or PD. The course includes simulation of clinical studies, models for relationships between drug exposure and effects, models for disease progression, PK and PD aspects on study design and model-informed dose individualization in clinic.

Instruction

The course assumes full-time studies. The main part of the work takes place in groups (2-8 students per group, dependent on workshop and student numbers).

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:

Certain in advance stated lectures and active participation in workshops.

Assessment

During the course, continuous examinations are conducted, consisting of oral presentations and a written report. The course is divided into five parts: WS Excel and PKPD (1,0 hp), WS Disease Progression (1,0 hp), WS Clinical Trial Simulation (2,0 hp), WS Model-based individualization (1,0 hp) and WS Clinical study design and analysis(2,5 hp).

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the disability coordinator of the university.

Other regulations

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

The course is an elective course of the pharmaceutical specialisation in the Master's Programme in Chemical Engineering.