Paediatric dose finding

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Modelling for paediatric development

Early drug development for paediatric patients is an area where PK/PD modeling is critical for safe and efficient dose selection. Due to the PK and PD differences between children and adults direct extrapolation from adults to children using a proportionality rule based on body size is often not appropriate. The European Medicines Agency paediatric guidelines (CHMP/EWP/147013/04 and EMEA/536810/08) emphasize the importance of physiology to predict systemic exposure in paediatric patients and suggest the use of physiologically-based PK models to predict characteristics in the paediatric population.