A Statistical Approach to PK/PD Analysis in Practice, ESCMID Postgraduate Technical Workshop

8 - 11 October 2012, Athens, Greece

Organisers
  • ESCMID PK/PD of Anti-Infectives Study Group (EPASG)
  • National and Kapodistrian University of Athens
  • Radboud University Medical Centre of Nijmegen
Course Coordinators
  • Eleftheria Mavridou, Nijmegen, NL
  • Joseph Meletiadis , Athens, GR
  • Johan W. Mouton, Nijmegen, NL
Course Objectives
  • Provide guidance on how to implement adequate statistical analysis to evaluate the pharmacokinetic and pharmacodynamic data
  • Understand PK/PD indices, principles of CART analysis and how to apply these to establish clinical breakpoints
  • Learn how to perform univariate and multivariate analysis, linear and nonlinear regression analysis, including the ins and outs of the Emax model
  • To clarify the principles of pharmacokinetic parameters (peak and trough levels, volume of distribution, area under the concentration curve) and the factors that affect them
  • Explain how to perform compartmental and non-compartmental pharmacokinetic analysis
  • Understand how to measure and analyse drug combination effects and how to determine synergy and antagonism, including the Greco and Bliss models
  • Perform analysis with different software programs

Course Venue

Titania Hotel Athens
Panepistimiou 52
Athens 106 78
Greece
Titania Hotel

Target Audience

The workshop is intended for 20–35 clinical microbiologists or scientists from academia (or companies) who work or want to work in the field of pharmacokinetics and pharmacodynamics and increase their knowledge and understanding in this area. Participants should have a basic understanding of statistics and ideally have some experience with PK/PD.

Course Programme

 

Presentations are availabe in the ESCMID Online Lecture Library.

 

Monday, 8 October 2012: Statistical analysis
13.00

Registration

13.15

Lunch
13.45Welcome and Introduction. Joseph Meletiadis
14.00Introduction to statistics. Pavol Jancura
15.00Linear and nonlinear regression models. Pavol Jancura
16.00Coffee break
16.15Hands-on exercises
18.15Interactive discussion. Concluding remarks of the first day
20.00

Welcome reception and dinner

 

Tuesday, 9 October 2012: PK/PD analysis
09.00

Pharmacokinetic analysis. Roger Brüggemann

10.00

Pharmacodynamic analysis. Joseph Meletiadis
11.00Coffee break
11.15Hands-on exercises
13.00Lunch
14.15PK/PD analysis in animals. Eleftheria Mavridou
15.15PK/PD analysis. Bridging animal with human data. William Hope
16.15Coffee break
16.30

Hands-on exercises. PK/PD analysis. Curve fitting. Training with computer expert programs

18.30Interactive discussion. Concluding remarks of the second day
Wednesday, 10 October 2012: In vitro-in vivo correlation
09.00

Simulating in vivo conditions in in vitro PK/PD models. Joseph Meletiadis

10.00

Analysis and simulations of in vitro and vivo time kill curves. Johan W. Mouton
11.00Coffee break
11.15Population pharmacokinetics. Anouk E. Muller
12.15Monte Carlo Simulations. Johan W. Mouton
13.15Lunch
14.15Determination of clinical breakpoints, CART analysis. William Hope
15.15Power calculations for PK/PD studies. Klaus Skovbo Jensen
16.15Coffee break
16.30Hands-on exercises. Curve fitting and simulation Training with computer expert programs
18.30Interactive discussion. Concluding remarks of the third day
Thursday, 11 October 2012: Literature review: dissecting the top 10 papers
09.00

Pharmacokinetics. Roger Brüggemann

10.00

PK/PD modelling. Johan W. Mouton
11.00Coffee break
11.15Animal models for PK/PD studies. Eleftheria Mavridou
12.15Bridging PK/PD with humans. Ursula Theuretzbacher
13.15Concluding remarks of the last day, closure of the workshop.
Faculty Members
  • Saiden Abbas, Nijmegen, NL
  • Roger Brüggemann, Nijmegen, NL
  • William Hope, Manchester, UK
  • Pavol Jancura, Nijmegen, NL
  • Klaus Skovbo Jensen, Copenhagen, DK
  • Eleftheria Mavridou, Nijmegen, NL
  • Joseph Meletiadis, Athens, GR
  • Johan W. Mouton, Nijmegen, NL
  • Anouk E. Muller, Rotterdam, NL
  • Ursula Theuretzbacher, Vienna, AT