SFKK18010U Pharmacometrics

Volume 2021/2022
Education

MSc Programme in Quantitative Biology and Disease Modelling - mandatory in the Technological Specialization

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmacy (Danish programme cand.pharm) - elective

MSc Programme in Pharmaceutical Sciences (Danish programme cand.scient.pharm) - restricted elective

MSc Programme in Pharmaceutical Sciences (English programme) - restricted elective

Content

Lectures covering PK-PD relationships, as well as distribution, metabolite kinetics, effect at receptor and ionchannel level, effect measurement, dose-effect relationships, population methods, simulation of PK-PD relationships and variability in PK-PD response and dosing to different patient populations.

Computer sessions for pharmacokinetic pharmacodynamic modeling using the program Phoenix WinNonlin, Berkeley Madonna and Microsoft Excel.

Learning Outcome

At the end of the course, students are expected to be able to:

Knowledge

  • demonstrate knowledge of pharmacokinetic (PK) and pharmacodynamic (PD) in the individual as well as the population
  • understand how to calculate PK and PD parameters and use them in a quantitative description of the interaction between a drug and the body over time.
  • obtain knowledge on variability in patient populations

 

Skills

  • obtain insight and hands-on experience with pharmacokinetic and –dynamic data analysis, based on different examples of plasma concentration-time course linked to therapeutic response.
  • obtain experience with the modelling software Phoenix WinNonlin and Microsoft Excel for data analysis.
  • apply knowledge on variability in patient populations to a PKPD analysis that can be used to describe variability in response in different patient segments and in drug research and illustrate development within the pharmaceutical industry.

 

Competences

  • design dosing strategies in different clinical situations based on their knowledge about PKPD (e.g. taking variations such as demographics, organfunction, pharmacogenetics, comobidity and interactions into account).
  • design experiments for the drug research and development based on their knowledge about PKPD

 

  • M. Rowland and T. Tozer, Clinical Pharmacokinetics and Pharmacodynamics, ed. 5, 2018 or ed. 4, 2011
  • Notes and lecture hand-outs available on the course homepage
If you are applying for the course as a credit transfer student, you must have passed Basic Pharmacology or Principles of Pharmacology or have acquired similar competencies in another course. Documentation for corresponding competencies in the form of a course description and an exam result must be attached to your application.
Participation and exam in either Basic Pharmacology or Principles of Pharmacology or similar, as the student should be familiar with the basic pharmacokinetic parameters and calculations, concepts determining variability in order to suggest individual dosing as well as knowledge and competence for reasoning on PKPD information.
Lectures: 20 lectures
Tutorials/computer sessions: 16 hours
  • Category
  • Hours
  • Lectures
  • 20
  • Preparation
  • 167
  • Theory exercises
  • 16
  • Exam
  • 3
  • Total
  • 206
Oral

Oral feedback will be given at tutorials and computer excercises

Credit
7,5 ECTS
Type of assessment
Written examination, 3 hours under invigilation
Examiners: Course teachers
Aid
Written aids allowed

Permitted aids: Textbooks, all written course material from the homepage.

There is access to the following at the exam at KU's exam venue:

  • R – Statistical programme
  • MathType formel programme
  • Maple
  • Digital Notes (It is allowed to upload notes for the ITX exam via digital exam. You will find a link to this feature from your exam in Digital Exam).

 

Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment

To achieve the grade 12 the student must be able to:

Knowledge

  • demonstrate knowledge of pharmacokinetic (PK) and pharmacodynamic (PD) in the individual as well as the population
  • understand how to calculate PK and PD parameters and use them in a quantitative description of the interaction between a drug and the body over time.
  • obtain knowledge on variability in patient populations

 

Skills

  • obtain insight and hands-on experience with pharmacokinetic and –dynamic data analysis, based on different examples of plasma concentration-time course linked to therapeutic response.
  • obtain experience with the modelling software Phoenix WinNonlin and Microsoft Excel for data analysis.
  • apply knowledge on variability in patient populations to a PKPD analysis that can be used to describe variability in response in different patient segments and in drug research and illustrate development within the pharmaceutical industry.

 

Competences

  • design dosing strategies in different clinical situations based on their knowledge about PKPD (e.g. taking variations such as demographics, organfunction, pharmacogenetics, comobidity and interactions into account).
  • design experiments for the drug research and development based on their knowledge about PKPD