Symposium E3
Medicines for the real life population: the science of extrapolation

Tuesday 23 May 2017
15:00-18:00
Stockholmsmässan : A3

Introduction

In drug research and in clinical practice frequently situations arise in which no information on the optimal dose is available in a relevant group of patients.  Examples of such situations include the selection of the dose in phase 1 clinical trials in healthy subjects and the selection of the dosage in special patients groups such as neonates, children, or patients with obesity.  This symposium addresses the scientific basis of extrapolation focusing on a diversity of  in vivo and in vitro  approaches,  including allometric scaling and physiology-based pharmacokinetic-pharmacodynamic modelling.   

Chair: Douwe D. Breimer (the Netherlands)

Programme

15:00 – 15:05 The science of extrapolation - Introductory remarks
Douwe D. Breimer, LACDR, Leiden University, the Netherlands

15:05 - 15:35 The science of extrapolation: in vitro and in vivo approaches
Amin Rostami-Hodjegan, University of Manchester, UK                                                           

15:35 - 16:05 Dose selection in phase 1 clinical trials in oncology
Jan Schellens, Netherlands Cancer Institute, the Netherlands

16:05 – 16:25 BREAK

16:25 – 16:50 Physiologically-based pharmacokinetic (PBPK) modeling and simulation in pediatric drug development
Andrea Edginton, University of Waterloo, Canada

16:50 – 17:15 Dose selection in obesity: effect of variation in size and function
Catherijne Knibbe, St. Antonius Hospital Nieuwegein, the Netherlands & LACDR, Leiden University, the Netherlands

17:15 – 17:40 Towards precision treatment: the impact of systems pharmacology
Hiroshi Suzuki, University of Tokyo Hospital, Tokyo, Japan

17:40 - 18:00 The science of extrapolation – panel discussion
Douwe D. Breimer, LACDR, Leiden University, the Netherlands