General provisions

The course will be given in English.

Entry requirements

For applicants within:

- The programme in Master of Science in Pharmacy: at least 150 credits within the programme including passed courses in

pharmacokinetics 7.5 credits, pharmacology and physiology. Furthermore, registration at all earlier courses within the

pharmacy program is required

- The programme in Bachelor of Science in Pharmacy: at least 120 credits within the programme including passed courses

in pharmacokinetics 7.5 credits, pharmacology and physiology. Furthermore, registration at all earlier courses within the

pharmacy program is required

- The programme in Master of Science in Chemical Engineering: at least 120 credits within the programme is required, and

courses corresponding to Pharmacokinetics 7.5 credits, Physiology 6 credits and Pharmacology 7.5 credits

- Master Programme in Drug Discovery and Development: admitted to the program including passed course in pharmacokinetics

- Master Programme in Pharmaceutical Modelling: admitted and complied prior courses within the program

- 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 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

After having completed the course, the student should be able to construct, understand and use drug-oriented computer models representing biological systems. Specifically, the student should be able to:

• Formulate compartmental models using mathematical equations.

• Describe and explain the differences between direct and indirect effect models.

• Describe how tolerance to drug effects can be included in pharmacodynamic models.

• Describe the fundamentals of physiologically based pharmacokinetic models and their application compared to traditional compartmental

models.

• Perform computer simulations of pharmacokinetic/pharmacodynamic models taken from the literature and use these models to address

scientific issues.

• Describe and apply methods for estimating drug elimination in man based on (non-clinical) laboratory data.

• Understand the methodology for fitting biological models to experimental data and to perform such model fitting in practice.

• Describe and use basic statistical methods for evaluation and interpretation of modelling results.

• Show a capacity for addressing scientific issues related to the results of work with biological models.

Content

The course deals with computer models for biological systems that are important in a drug development context. Specifically, the focus is on models for clinical pharmacokinetic and pharmacodynamic data, however, the course will also include models of systems that are of importance for preclinical research in the pharmaceutical field. Evaluation of modelling results is an important part of the course.

The course will also illustrate the use of the models for addressing scientific issues and aspects of study design. Technical, mathematical and statistical aspects on model fitting and non-linear regression form an integral part of the course.

Instruction

The studies will take place during the normal work week and the student should be prepared to attend full days Monday - Friday, each week. The main part of the work is performed in groups (2-4 students).

Teaching is a mixture of lectures, workshops, demonstrations of software and exercises in the use of this software. The workshops are tasks to be solved and reported in groups as well as individually in some cases.

There are several parts of the course that are compulsory; the course introduction and the introduction to and presentation of each workshop.

Assessment

During the course several examinations will take place and will comprise an oral and/or written presentation.

Passing the course requires, apart from approved examinations in each part, presence during compulsory sections of the course.