Does size matter? : bridging and dose selection in paediatric trials

Cella, M. (2011)

Doctoral Thesis

__Does size matters? Bridging and dose selection in paediatric trials__ investigates the use of pharmacokinetic (PK) modelling to support dosing recommendation in children during drug development. To date, empiricism still leads the choice of the dose to administer to children during clinical trials. Setting the exposure to the drug obtained in adults as the target of the bridging procedure, assessing the PK differences between adults and children with a model-based approach and bridging such exposure to paediatric patients, more accurate paediatric dose recommendations can be provided to paediatric clinical investigators. This thesis addresses the methodological issues of pharmacokinetic bridging and its implementation in paediatric clinical trials.

• Pharmacokinetic bridging
• Paediatric interpolation
• Paediatric drug development
• Model-based research
• Drug combinations
• Dose extrapolations
• Dose adjustment
• Allometric model
• Adaptive design

• All authors: Cella, M.
• Supervisor: Danhof, M.
• Co-supervisor: Della Pasqua, O.E.
• Qualification: Doctor (dr.)
• Awarding Institution: Faculty of Science, Leiden University
• Date: 2011-10-12
• ISBN (print): 9789461691231
• Sponsorship: LACDR GSK