Model-based approach for methoxy polyethylene glycol-epoetin beta drug development in paediatric patients with anaemia of chronic kidney disease.

Pascal ChanuFranz SchaeferBradley A WaradyClaus Peter SchmittBruno ReignerGabriel SchnetzlerSylvie Meyer ReignerMark EisnerArlette WeichertNicolas Frey

Published in: British journal of clinical pharmacology (2020)

These analyses have facilitated optimisation of the C.E.R.A. development programme in paediatric patients with anaemia of CKD to provide this patient population with faster access to the drug while avoiding unnecessary clinical trial exposure and related monitoring burden in children.

Keyphrases

chronic kidney disease
clinical trial
end stage renal disease
intensive care unit
emergency department
iron deficiency
study protocol
young adults
case report
phase ii
randomized controlled trial
double blind
risk factors
drug induced
peritoneal dialysis