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 and complied prior courses within the program

- 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

* 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 PD models that describe disease progression with and without simultaneous drug treatment

* Apply 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

* 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 or scholarly journal

* Write a report, in proper English on a performed task in a format similar to a scientific report or 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, , simulation of clinical studies, presentation 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 (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. The course is divided into five parts that are examined through oral presentations (3 as 1.0 hp and 1 as 2.5 hp) and a written report (1 as 2.0 hp). 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.

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.