First dose in children: physiological insights into pharmacokinetic scaling approaches and their implications in paediatric drug development

Dose selection for “first in children” trials often relies on scaling of the pharmacokinetics from adults to children. Commonly used approaches are physiologically-based pharmacokinetic modeling (PBPK) and allometric scaling (AS) in combination with maturation of clearance for early life. In this in...

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Detalles Bibliográficos
Autores principales: Strougo, Ashley, Eissing, Thomas, Yassen, Ashraf, Willmann, Stefan, Danhof, Meindert, Freijer, Jan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2012
Materias:
Original Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3306781/
https://www.ncbi.nlm.nih.gov/pubmed/22311388
http://dx.doi.org/10.1007/s10928-012-9241-9

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3306781/
https://www.ncbi.nlm.nih.gov/pubmed/22311388
http://dx.doi.org/10.1007/s10928-012-9241-9

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