Syllabus for Models for Biological Systems

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
• Give oral presentations in English
• Write a report, in English, on project results in a format similar to a scholarly journal

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.

The course will be given in English.

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

Assessment

Passing the course requires approved oral presentation of simulation project (3 credits) and oral and written presentation of estimation project (4.5 credits)

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 University's disability coordinator.