The DEEP project has received research funding from the European Union under the 7th Framework Programme
The Leiden/Amsterdam Center for Drug Research (LACDR) of the University of Leiden (UL) is a joint venture between the university’s Faculty of Mathematics and Natural Sciences and the Faculty of Sciences of the Vrije Universiteit Amsterdam. The UL-LACDR aims to be one of the leading academic centers in the world in learning, in teaching, and in advancing innovative drug research, developing crucial knowledge and expertise for drug discovery, evaluation and clinical application. This also involves fundamental understanding of drug action as the basis for efficacy and safety of drugs. The University of Leiden was 60th in the 2009 THE-QS Rankings. The Division of Pharmacology is a world leader in PK/PD modelling and has research programme dedicated to the evaluation of pharmacokinetics and drug response in children. LACDR will be responsible for the PK evaluations described in WP3.
Main tasks in the project
The UL-LACDR will coordinate and manage all activities of WP3. This will involve the planning, implementation, analysis and reporting of the results of PK study to select the dosing regimen in children aged 2-10 years and provide recommendations for dose adjustment. To achieve the aforementioned objectives, a randomised clinical trial will be performed in children. Drug exposure in plasma and ferritin response will be analysed using nonlinear mixed effects modelling. Subsequently, based on the PK/PD relationship, a formal clinical trial simulation will be performed to explore relevant trial scenarios for the evaluation of non-inferiority in the efficacy/safety study.
2300 RA Leiden – The Netherlands