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First published on May 19, 2008, doi:10.1177/0091270008318218

The Journal of Clinical Pharmacology 2008;48:837.

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©© 2008 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270008318218

Article

Population Pharmacokinetic Modeling of Epoetin Delta in Pediatric Patients With Chronic Kidney Disease

William Knebel 1*, Mary Palmen 2, James A. Dowell 2, and Marc Gastonguay 1

1 Metrum Research Group LLC
2 Shire Pharmaceuticals

* To whom correspondence should be addressed. E-mail: billk{at}metrumrg.com.


  Abstract
This analysis quantifies the population pharmacokinetics of subcutaneous and intravenous epoetin delta, an epoetin produced in a human cell line, in pediatric patients with chronic kidney disease and estimates the effects of covariate factors on epoetin delta and epoetin alfa pharmacokinetic parameters. Erythropoietin serum concentration data, taken from a phase III study conducted in 60 patients aged 1 to 17 years, were best described by a 1compartment model with first-order absorption and elimination. The typical point estimates were clearance (0.268 L/h), central volume of distribution (1.03 L), absorption rate constant (0.0554 h-1), and bioavailability (0.708) for a 35-kg male ≤10 years who was predialysis and on subcutaneous epoetin delta treatment. Erythropoietin pharmacokinetic parameters were similar in pediatric patients as compared with adults when scaled by weight. The subcutaneous administration of epoetin alfa exhibited lower systemic bioavailability than subcutaneous administration of epoetin delta.
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