General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children

Pharmacometric modelling plays a key role in both the design and analysis of regulatory trials in paediatric drug development. Studies in adults provide a rich source of data to inform the paediatric investigation plans, including knowledge on drug pharmacokinetics (PK), safety and efficacy. In children, drug disposition differs widely from birth to adolescence but extrapolating…

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Spotlight on a National Hub: Portugal

STAND4Kids is the Portuguese National Hub for paediatric clinical trials. Our story dates back to 2018, as an emerging network born within c4c. We are fully dedicated to build a sustainable, lean, fit-for-purpose, national paediatric trial network that facilitates high-quality, child/family- and clinically-relevant, operationally efficient paediatric clinical trials in Portugal.

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