ArticleBritish journal of clinical pharmacology2007
Population pharmacokinetics of darbepoetin alfa in healthy subjects.
Article in British journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The relationship between drug clearance and body size: systematic review and meta-analysis of the literature published from 2000 to 2007.Clinical pharmacokinetics · 2012Pooled it
- Population pharmacokinetics meta-analysis of recombinant human erythropoietin in healthy subjects.Clinical pharmacokinetics · 2007Pooled it
- Population Pharmacokinetics of Epcoritamab Following Subcutaneous Administration in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma.Clinical pharmacokinetics · 2025Trial
- Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESPDrug design, development and therapy · 2021Trial
- Population Pharmacokinetics of Darbepoetin in Infants Following Single Intravenous and Subcutaneous Dosing.Journal of pharmaceutical sciences · 2017Trial
- Population Pharmacokinetics of Darbepoetin Alfa in Conjunction with Hypothermia for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy.Clinical pharmacokinetics · 2015Trial
- Population pharmacokinetics of darbepoetin alpha in peritoneal dialysis and non-dialysis patients with chronic kidney disease after single subcutaneous administration.European journal of clinical pharmacology · 2009Trial
- Pharmacokinetics and pharmacodynamics of the erythropoietin Mimetibody construct CNTO 528 in healthy subjects.Clinical pharmacokinetics · 2009Trial
- Development and evaluation of a population pharmacokinetic-pharmacodynamic model of darbepoetin alfa in patients with nonmyeloid malignancies undergoing multicycle chemotherapy.The AAPS journal · 2006Trial
- Erythropoietin in Tumor Immunity: Mechanistic Evidence, Clinical Cautions, and Translational Opportunities.Cancers · 2026Review
- Pharmacokinetics-Based Design of Subcutaneous Controlled Release Systems for Biologics.CPT: pharmacometrics & systems pharmacology · 2025Article
- Development of Romiplostim for Treatment of Primary Immune Thrombocytopenia From a Pharmacokinetic and Pharmacodynamic Perspective.Clinical pharmacokinetics · 2016Review
- Use of Modeling and Simulation in the Design and Conduct of Pediatric Clinical Trials and the Optimization of Individualized Dosing Regimens.CPT: pharmacometrics & systems pharmacology · 2015Article
- Generating Virtual Patients by Multivariate and Discrete Re-Sampling Techniques.Pharmaceutical research · 2015Article
- Clinical pharmacokinetics and pharmacodynamics of erythropoiesis-stimulating agents.Clinical pharmacokinetics · 2013Review
- A biomathematical model of human erythropoiesis under erythropoietin and chemotherapy administration.PloS one · 2013Article
- Pharmacokinetic predictions for patients with renal impairment: focus on peptides and protein drugs.British journal of clinical pharmacology · 2012Article
- Erythropoietin pharmacology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2007Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo develop and evaluate a population pharmacokinetic (PK) model of the long-acting erythropoiesis-stimulating protein, darbepoetin alfa in healthy subjects.
methodsPK profiles were obtained from 140 healthy subjects receiving single intravenous and/or single or multiple subcutaneous doses of darbepoetin alfa (0.75-8.0 microg kg(-1), or either 80 or 500 microg). Data were analysed by a nonlinear mixed-effects modelling approach using NONMEM software. Influential covariates were identified by covariate analysis emphasizing parameter estimates and their confidence intervals, rather than stepwise hypothesis testing. The model was evaluated by comparing simulated profiles (obtained using the covariate model) to the observed profiles in a test dataset.
resultsThe population PK model, including first-order absorption, two-compartment disposition and first-order elimination, provided a good description of data. Modelling indicated that for a 70-kg human, the observed nearly twofold disproportionate dose-exposure relationship at the 8.0 microg kg(-1)-dose relative to the 0.75 microg kg(-1)-dose may reflect changing relative bioavailability, which increased from approximately 48% at 0.75 microg kg(-1) to 78% at 8.0 microg kg(-1). The covariate analysis showed that increasing body weight may be related to increasing clearance and central compartment volume, and that the absorption rate constant decreased with increasing age. The full covariate model performed adequately in a fixed-effects prediction test against an external dataset.
conclusionThe developed population PK model describes the inter- and intraindividual variability in darbepoetin alfa PK. The model is a suitable tool for predicting the PK response of darbepoetin alfa using clinically untested dosing regimens.
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