Archives of Disease in Childhood
June 1, 2023
Esther van Duijn, Steven Erpelinck, Wouter Vaes
Introduction: An overview is given on the use of microdosing/microtracing studies for the safer and faster development of drugs in children. In a microdosing study a very small amount of radiolabelled (often 14C) drug is administered to a human volunteer. Using accelerator mass spectrometry extremely low amounts of the drug and metabolites can be traced and quantified. Methods: Several...
Clinical Pharmacokinetics
January 7, 2022
Z. Oesterreicher, Sabine Eberl, B. Wulkersdorfer et al.
Background and Objective In microdose studies, drug pharmacokinetics is measured in humans after administration of subtherapeutic doses. While previous microdose studies focused primarily on plasma pharmacokinetics, we set out to evaluate the feasibility of microdosing for a pharmacokinetic assessment in subcutaneous tissue and epithelial lining fluid. Methods Healthy subjects received a single...
Clinical Pharmacokinetics
February 2, 2017
M. Mooij, Esther van Duijn, C. Knibbe et al.
BackgroundWe previously showed the practical and ethical feasibility of using [14C]-microdosing for pharmacokinetic studies in children. We now aimed to show that this approach can be used to elucidate developmental changes in drug metabolism, more specifically, glucuronidation and sulfation, using [14C]paracetamol (AAP).MethodsInfants admitted to the intensive care unit received a single oral...
Clinical Pharmacokinetics
January 2016
Sieto Bosgra, Maria L H Vlaming, Wouter Vaes
Microdosing studies allow clinical investigation of pharmacokinetics earlier in drug development, before all high-dose safety concerns have been sorted out. Furthermore, microdosing allows inclusion of target groups that are inadmissible in high-dose phase I trials. A potential concern when considering a microdosing study is that a particular drug candidate may display non-linear...
Clinical Pharmacology & Therapeutics
August 2015
Maria L H Vlaming, Esther van Duijn, M R Dillingh et al.
Preclinical development of new biological entities (NBEs), such as human protein therapeutics, requires considerable expenditure of time and costs. Poor prediction of pharmacokinetics in humans further reduces net efficiency. In this study, we show for the first time that pharmacokinetic data of NBEs in humans can be successfully obtained early in the drug development process by the use of...