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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 2017: March 6th-10th, 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

9 am – 10.45 amPopulation model development I: Framework, submodelsModel assessment and diagnosticsSimulations with hands-onPopulation model development III: PK/PD analysis
15 minCoffee break
11 am – 12.45 pmPopulation model buildingHands-on: Population PK modelling - Model development II (NONMEM/PsN, Xpose/R)Advanced model evaluation techniques I with hands-onSpecial features in population analysis
60 minLunch break
1.45 pm – 4.45 pm[Start 1 pm]

Welcome and Introduction

Recap A1

Population approach I

Population approach II
Population PK modelling - Model development I
(PsPad, Cluster: NONMEM/PsN)

Hands-on: Population PK modelling - Model evaluation
(NONMEM/PsN, Xpose/R)
Population model development II:
Covariate submodel

Covariate PK model building
(NONMEM/PsN, Xpose/R)
Advanced model evaluation techniques II:
with hands-on (+Pirana)

Estimation algorithms
(e.g. NONMEM, Monolix)

Optional seminar:
15 minCoffee break
5 - 6 pmWrap-up:
Questions & Answers
Presentation of exercises
Presentation of exercises
Questions & Answers
EveningSocial Event (jointly with A4 Systems Biology module, details will be announced in the course)

Contributions: Prof. Charlotte Kloft (main lecturer), N.N., Jane Knöchel

External contributions: Prof. Dr. Thorsten Lehr (Universität des Saarlandes), Dr. André Schäftlein (Klinikapotheke Bad Berka)


Information for this year's participants

  • Venue: Seminar room 134, Institute of Pharmacy/Freie Universitaet Berlin, Kelchstr. 31, 12169 Berlin

  • Hard- and software
    • Please bring you own laptop.
    • Phoenix WinNonlin® (Pharsight): will be provided on a PC during the module (if you have it installed: at least version 6.3)
    • Berkeley Madonna® (Macey&Oster). Demo version is sufficient (download here).
    • MS Excel® (Microsoft): only for those who prefer Excel for making tables and plots (you should be familiar with basic tools, see, e.g. Erste Schritte mit Excel 2010)

  • Literature
    • 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.

  • 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/beamer.