General provisions

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

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 (150 credits), and b) knowledge corresponding to 60 credits within the subject Pharmacy, Pharmaceutical science or 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.

Content

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.

Instruction

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.

Assessment

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.

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