SFKKB9001U Pharmacokinetics and Pharmacodynamics

Volume 2013/2014
Education
MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective
Content
Lectures covering PK-PD relationships, as well as distribution, metabolite kinetics, 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 and Microsoft Excel
Learning Outcome
Pharmacokinetics (PK) and pharmacodynamics (PD) is a quantitative description of the interaction between a drug and the body over time and forms the basis for choice of drug and decisions on dose magnitude and dosing interval. The objective of the course is to provide insight and hands-on experience with pharmacokinetic and –dynamic data analysis, based on different examples of plasma concentration-time course of drug and link to therapeutic response. The modelling software Phoenix WinNonlin and Microsoft Excel will be used for data analysis. The students will be introduced to variability in patient populations and how PKPD analysis can be used to describe variability in response in different patient segments and in drug research and development within the pharmaceutical industry. Furthermore they will obtain knowledge about dosing strategies in different clinical situations.
Literature
  • M. Rowland and T. Tozer, Clinical Pharmacokinetics and Pharmacodynamics, ed. 4, 2011
  • Notes and lecture hand-outs available on the course homepage
Participation and exam in either Almen Farmakologi 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: 30 lectures
Tutorials/computer sessions: 12 hours
  • Category
  • Hours
  • Exam
  • 80
  • Lectures
  • 30
  • Preparation
  • 84
  • Theory exercises
  • 12
  • Total
  • 206
Credit
7,5 ECTS
Type of assessment
Written examination, 3 hours under invigilation
Permitted aids: Textbooks, all written course material from the homepage and calculator and computer with Microsoft Excel and Word
Examiners: Course teachers
Aid
Written aids allowed
All written aids.

Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-eksamen.ku.dk/pc_exam students will at this exam also have access to MathType and the possibility to use a USB stick (for notes etc.)
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment
Pass criteria The student must demonstrate how to manage and analyse basic pharmacokinetic-pharmacodynamic data to form a basis for reasoning and for deriving conclusions that can be used in drug development, for inclusion in patient information and in a clinical context. Description of grades 12 - Excellent performance The examination answers are accurate, clear and precise. The student demonstrates a broad overview and detailed knowledge and a competence of the problem examined. The student demonstrates a broad knowledge of the essentials of the concepts in PK-PD. The student • Clearly demonstrates understanding and managing the data necessary to characterize the pharmacokinetics and pharmacodynamics of a given drug • Clearly demonstrates the basic skills to process, manage and analyse data that can be translated into the drug treatment of patients. • Clearly demonstrates how to use and manage pharmacokinetic and pharmacodynamic data in the development of drugs as well as in guidelines for therapy monitoring, reasoning and guidance. 7 - Good performance The examination answer are structured and reasonably clear and precise. The student demonstrates overview and knowledge relevant for using and managing PK-PD information. The student • Demonstrates relatively well the understanding to generate the data necessary to characterize the pharmacokinetics and pharmacodynamics of a given drug • Demonstrates relatively well the basic skills to treat, manage and analyse data that can be translated into the drug treatment of patients. • Demonstrates relatively well how to use and manage pharmacokinetic and pharmacodynamic data in the development of drugs, as well as in guidelines for therapy monitoring, reasoning and guidance. 02 - Acceptable performance The examination answers are somewhat badly structured, a bit unclear and somewhat imprecise. The overview is not broad, which also means that the PK-PD conclusions are not absolutely correct. Overall knowledge is lacking in some respects, which in some instances prevents accurate conclusions. The student • Acceptably demonstrates the understanding the data necessary to characterize the pharmacokinetics and pharmacodynamics of a given drug • Acceptably demonstrates the basic skills to treat, manage and analyse data that can be translated into the drug treatment of patients. Acceptably demonstrates how to use and manage pharmacokinetic and pharmacodynamic data in the development of drugs as well as guidelines for therapy monitoring, reasoning and guidance