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A3: Introduction to population analysis

The module introduces the basic concept in population analysis. The objective of the module is to familiarise the participants with the population analysis approach by discussing its framework and different concepts. In terms of methodological approaches of data analysis the emphasis will be laid on the nonlinear mixed-effects modelling approach.


Knowledge and technical abilities on various model diagnostics and (advanced) evaluation techniques will be conveyed for critical assessment of the methodology used and models developed.

The module will be complemented by multiple Hands-on sessions with the software packages NONMEM™/PsN (analyses will be performed on a Linux-Cluster), R/Xpose™ and be based on case studies.

Frequency: Every year in August/September.
 
Language: English
 
Module in 2024: 12-16 Aug, 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 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
Hands-on:
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

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

Estimation algorithms
(e.g. NONMEM, Monolix)
Summary/Closing

Optional seminar:
tba
15 minCoffee break
5 - 6 pmWrap-up:
Questions & Answers
Wrap-up:
Presentation of exercises
Wrap-up:
Presentation of exercises
Wrap-up:
Questions & Answers
EveningSocial Event (either during A3 or A4 module)

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.
  • MS Excel® (Microsoft, at least version 2003)
  • For all other software programs it would be nice if you have it installed, but it will also be provided on a PC during the module:
  • PsPad (or other text editor); download here
  • WinSCP; download here
  • PuTTY; download here
  • R; download here.  Please load (and install) xpose4 package into R
  • NONMEM®, Monolix®, PsN, Pirana, SAS, R: provided or demonstrated during the A3 Module

Literature

  • Detailed references will be provided during the course.
  • H. Derendorf, T. Gramatté, H.G. Schaefer, A. Staab (eds.): Pharmakokinetik kompakt Grundlagen und Praxisrelevanz, Wissenschaftliche Verlagsgesellschaft, Stuttgart, 3rd ed., pp. 315, 334-347, 2011
  • R.E. Port: Populations-Pharmakokinetik und individuelle Dosisanpassung, in: Zeller, zur Hausen (ed.): Onkologie, 16th suppl sheets (Erg.Lfg.), 2003.
  • L. Aarons: Population pharmacokinetics: theory and practice. Brit. J. Clin. Pharmacol. 32: 669-670 (1991)