Detalle Publicación


Scaling dose-exposure-response from adults to children

Libro: Fundamentals of pediatric drug dosing
Autores: Skottheim-Rusten, I.; Nordmark, A.; Cole, S.; Standing, J. F.; Friberg-Hietala, S.; Zhao, W.; Gigante, V.; Karin-Hamberg, A; Pons, G.; Garrido Cid, María Jesús; Taminiau, J.; Benda, N.; Lentz, F.; Musuamba-Tshinanu, F.; Thomson, A.; Tomasi, P.; Ollivier, C.; Herold, R.; Manolis, E.
Lugar de Edición: Cham
Editorial: Springer International Publishing
Fecha de publicación: 2016
Página Inicial - Final: 93 - 107
ISBN: 978-3-319-43754-5
Resumen: For a paediatric development to be rationally informed by all available knowledge, it is necessary to systematically collect and learn from available data, expert knowledge and prior developments. Aspects such as drug formulation, bioanalytical methodology, pharmacokinetics/pharmacodynamics (PK/PD), study design and statistics should be considered when defining a development plan. In this context, model informed drug discovery and development (MID3) methodology [1] is likely to prove useful.