Trial reportJournal of clinical pharmacology2012
Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575.
Trial report in Journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07025681 (Randomized, Double-blinded, Two-treatment, Two-periods, Single-dose, Crossover, PK, PD, Safety, and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex of Janssen-Cilag Ltd in Healthy Adult Subjects), which is not on this map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Randomized, Double-blinded, Two-treatment, Two-periods, Single-dose, Crossover, PK, PD, Safety, and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex of Janssen-Cilag Ltd in Healthy Adult Subjects
Who cites it
19 citing papers in PubMed, 38 citations in OpenAlex.
- Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (AvastinCancer chemotherapy and pharmacology · 2020Trial
- Comparable pharmacokinetics and pharmacodynamics of two epoetin alfa formulations EporonDrug design, development and therapy · 2017Trial
- Mechanism-Based Pharmacokinetic/Pharmacodynamic Modeling for Iron-Regulated Hematopoietic Stem and Progenitor Cells' Commitment toward Erythroid and Megakaryocytic Lineages.ACS pharmacology & translational science · 2025Article
- Novel Combination of Erythropoietin and Romiplostim to Treat Chemotherapy-Induced Anemia and Thrombocytopenia via Pharmacodynamic Interaction on Hematopoietic Stem and Progenitor Cells.ACS pharmacology & translational science · 2023Article
- Scaling Pharmacodynamics from Rats to Humans to Support Erythropoietin and Romiplostim Combination Therapy to Treat Erythropoietin-Resistant Anemia.Pharmaceutics · 2023Article
- A Novel Combination Therapy of Erythropoietin and Thrombopoietin to Treat Erythropoietin-Resistance anemia.Pharmaceutical research · 2022Article
- Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study.EClinicalMedicine · 2021Article
- Concept of Pharmacologic Target-Mediated Drug Disposition in Large-Molecule and Small-Molecule Compounds.Journal of clinical pharmacology · 2020Review
- Dose Correction for a Michaelis-Menten Approximation of a Target-Mediated Drug Disposition Model with a Multiple Intravenous Dosing Regimens.The AAPS journal · 2020Article
- Application of Pharmacokinetic-Pharmacodynamic Modeling in Drug Delivery: Development and Challenges.Frontiers in pharmacology · 2020Review
- Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies.The AAPS journal · 2019Article
- A model of hematopoietic bone marrow apoptosis during growth factor deprivation in combination with a cytokine.Theoretical biology & medical modelling · 2018Article
- Application of Pharmacometric Analysis in the Design of Clinical Pharmacology Studies for Biosimilar Development.The AAPS journal · 2018Article
- A cell-level model of pharmacodynamics-mediated drug disposition.Journal of pharmacokinetics and pharmacodynamics · 2016Article
- A Tutorial on Target-Mediated Drug Disposition (TMDD) Models.CPT: pharmacometrics & systems pharmacology · 2015Article
- A model of hematopoietic stem cell proliferation under the influence of a chemotherapeutic agent in combination with a hematopoietic inducing agent.Theoretical biology & medical modelling · 2014Article
- Clinical pharmacokinetics and pharmacodynamics of erythropoiesis-stimulating agents.Clinical pharmacokinetics · 2013Review
- Quantitative assessment of minimal effective concentration of erythropoiesis-stimulating agents.CPT: pharmacometrics & systems pharmacology · 2013Article
- Romiplostim dose-response in patients with myelodysplastic syndromes.British journal of clinical pharmacology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
Abstract
The aim of this study was to develop an integrated pharmacokinetic and pharmacodynamic (PK/PD) model and assess the comparability between epoetin alfa HEXAL/Binocrit (HX575) and a comparator epoetin alfa by a model-based approach. PK/PD data-including serum drug concentrations, reticulocyte counts, red blood cells, and hemoglobin levels-were obtained from 2 clinical studies. In sum, 149 healthy men received multiple intravenous or subcutaneous doses of HX575 (100 IU/kg) and the comparator 3 times a week for 4 weeks. A population model based on pharmacodynamics-mediated drug disposition and cell maturation processes was used to characterize the PK/PD data for the 2 drugs. Simulations showed that due to target amount changes, total clearance may increase up to 2.4-fold as compared with the baseline. Further simulations suggested that once-weekly and thrice-weekly subcutaneous dosing regimens would result in similar efficacy. The findings from the model-based analysis were consistent with previous results using the standard noncompartmental approach demonstrating PK/PD comparability between HX575 and comparator. However, due to complexity of the PK/PD model, control of random effects was not straightforward. Whereas population PK/PD model-based analyses are suited for studying complex biological systems, such models have their limitations (statistical), and their comparability results should be interpreted carefully.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.