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Advancing Pediatric Drug Development

Decentralized Clinical Trials Edited

Pooled analyses can only be conducted if the included studies use the same study design and statistical models, and if their respective populations were homogeneous.

Decentralized clinical trials can improve trial homogeneity as well as participant diversity, eliminate geographic barriers, allow for participation in clinical trials through local practices, allow for local subsequent testing, and eliminate participant... more »

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Advancing Pediatric Drug Development

Intranasal Antipyretic development in Pediatric Poulation Edited

Pediatric patients with Respiratory illnesses generally arrive to the hospital with high fevers and quite irritable. During this time their respiratory rate and work of breathing often looks much worse until the fever is controlled and mild analgesia is established. ┬áIf normothermia can be maintained at home quickly via the use of an intranasal option, these patients may not progress in illness past the tipping point... more »

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Advancing Pediatric Drug Development

What variables/parameters/phenomena depend on age, and what is the link? Can it be explained by body or organ weights only? Edited

Data from J. Valentin, 2003, 'Basic anatomical and physiological data for use in radiological protection: reference values', (Annals of the ICRP, vol. 32, no. 3-4, pp. 1-277 (doi:10.1016/s0146-6453(03)00002-2)) can be used in PBPK modeling to adapt the weight of each organ to the age of the virtual patient. This allows to have differences between the adult and pediatric populations. However we did not have the relevant... more »

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