Development of Pediatric Dosing for Mepolizumab in Severe Asthma Based on Extrapolation of Data From Adult Patients and a Phase II Open‐Label Pediatric Trial.

The benefit–risk profile of mepolizumab in severe asthma was established through clinical trials in adults, leading to EU and US approvals in 2015. To support a pediatric indication (≥6 years), an extrapolation approach was implemented. This extrapolation and its validation were informed by data fro...

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Publicado en:Journal of Clinical Pharmacology Vol. 66; no. 2; pp. 1 - 11
Autores principales: Gupta, Atul, Pouliquen, Isabelle J., Phipatanakul, Wanda, Austin, Daren, Whelan, Glenn, Price, Robert G., Finney‐Hayward, Tricia, Derey, Sabine, Steinfeld, Jonathan
Formato: research tables/charts Journal Article
Publicado: Wiley-Blackwell Feb2026
Acceso en línea:Ver este registro en EBSCOhost