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A1: Introduction to pharmacokinetics and pharmacodynamics (PK/PD)

The module introduces the basic concepts in pharmacokinetics (PK) and pharmacodynamics (PD). To meet this objective, PhD students will acquire knowledge, ability and critical evaluation competencies in the understanding of (non)clinical PK concepts, (non)clinical PD concepts: Different methodological approaches of data analysis will be discussed including model diagnostics.


A major focus is laid on the interpretation and assessment of clinical impact of PK, PD parameter values as well as the strength of simulation-based analysis. Finally, an introduction to the theoretical background of applied mathematics will round up the seminars.

The module will be complemented by multiple Hands-on sessions with the software packages Phoenix/WinNonlin™, Berkeley Madonna™ and be based on case studies.

Frequency: Every year in March/April.

Language: English

Module in 2020: 9-13 March, Freie Universität Berlin/Germany. The schedule below is generic. For each PhD student year, the specific schedule will be sent via email to the participants.

Illustrative schedule

TimeMondayTuesdayWednesdayThursdayFriday
9:00 – 10.45Start: at 10:00. Welcome, IntroductionHands-on Disc.

PK compartmental models
Basics in (non)clinical pharmacodynamics (PD) INonlinear regressionBerkeley Madonna “Modelling and analysis of dynamic systems” Basic concepts
15 minCoffee break
11:00 – 12.45Basics in (non)clinical pharmacokinetics (PK) IPK modelling/PK data analysis I

Hands-on I: CMT analysis (Phoenix WinNonlin)
Basics in (non)clinical pharmacodynamics (PD) II PD models

Hands-on PD models (Phoenix WinNonlin)
Analytical solution of linear ordinary differential equationsBerkeley Madonna: Examples & Hands-on

Guest Talk: Pharmacometrics for decision-making
60 minLunch break
13.45 – 18.00 (with coffee break in-between)Basics in (non)clinical pharmacokinetics (PK) II

Hands-on NCA (Phoenix WinNonlin)
Hands-on II: CMT analysis with different modelling and mathematical options (Phoenix WinNonlin)

Hands-on Disc. Model diagnostics Modelling strategies Decision-making, Team communication
Hands-on Disc.

Pharmacokinetic/ pharmacodynamic (PK/PD) models: PK/PD Link models

Hands-on PK/PD models (Phoenix WinNonlin)

Wrap-up. Questions & Answers
ODE in matrix formulation and Hands-on

Numerical solution of ordinary differential equations

In silico simulations and Guided examples
Summary, Feedback. Closing (-14:30)
15 minCoffee break
- 18:30Wrap-up: Questions & AnswersWrap-up: Questions & AnswersPhD Discussion Forum: Open discussion of your PhD projects (informal atmosphere)Wrap-up:
Questions & Answers

Contributions:

  • Prof. Charlotte Kloft; theoretical lectures
  • PharMetrX PhD students (2nd/3rd year); hands-on exercises
  • External contributions by our faculty members

PhD discussion forum

  • Prepare yourself to present your PhD project/proposal to the group with (i) content (e.g. background, objectives, methods, first results, etc.) and (ii) points for discussion (open questions, problems, ideas, etc.).
  • You may use a whiteboard/video projector.

Hard- and software

  • Please bring you own laptop.
  • Phoenix WinNonlin® (Pharsight): will be provided on a PC during the module
  • Berkeley Madonna® (Macey&Oster). Demo version is sufficient (download here).

Literature

  • Detailed references will be provided during the course.
  • Basics: Administration routes; absorption, distribution, metabolism and excretion processes
    (e.g. E. Mutschler (ed.): Arzneimittelwirkungen. Wiss. Verlagsgesellschaft, Stuttgart, 10th ed., 2013;
    W.A. Ritschel, G.L. Kearns (eds.): Handbook of Basic Pharmacokinetics. American Pharmaceutical Association, 7th ed., 2009).
  • Kinetics of reactions, basic terms in PK and PD, e.g. H. Derendorf, T. Gramatté, H.G. Schaefer, A. Staab (eds.): Pharmakokinetik kompakt: Grundlagen und Praxisrelevanz, Wiss. Verlagsgesellschaft, Stuttgart, 3rd ed., 2011; W.A. Ritschel, G.L. Kearns (eds.): Handbook of Basic Pharmacokinetics. American Pharmaceutical Association, 7th ed., 2009).
  • Basics: “Why data modelling?”, e.g. D.W.A. Bourne (ed.): Mathematical Modeling of Pharmacokinetic Data. Technomic Publishing Company, Lancaster, USA, Basel, pp 1-29, 1995).
  • Basics: Differential equations, e.g. B. D. Storey, Needham, MA: Teaching material available online, 2nd item “Numerical solutions to differential equations”, 1st chapter, 2003.