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eBulletin  |  September 2013

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Bioanalytical Assays Now Available for Intravenously Delivered
Iron Products

Algorithme Pharma has successfully developed several bioanalytical methods for the determination of Pharmacokinetics and Bioequivalance with intravenously delivered iron products*. Our colorimetric-based assays have been developed so that parameters (reaction kinetic, incubation time, reagent / analyte ratio) have been optimized and are reproducible throughout the concentration ranges.

In our assays, selectivity (e.g. lipemia & hemolysis) was assessed in naïve human serum lots and iron baseline levels were determined in selected serum pools for Quality Control samples. The assays were then shown to measure Transferrin-Bound Iron (TBI) with no interference from the iron-carbohydrate complex. This ensured that the TBI concentrations measured were accurate.

* Ferumoxytol & Iron Sucrose

Precision and AccuracyTotal Serum Iron
(TSI) Assay
Transferrin-Bound Iron
(TBI) Assay
Between-run Within-run Between-run Within-run
% CV 1.0 - 6.7 0.1 - 4.3 3.6 - 9.2 0.8 - 4.4
% Nominal 94.6 - 104.6 98.5 - 107.5 89.8 - 103.2 92.6 - 100.2
% Total Error
2.5 - 12.1 0.9 - 11.9 4.2 - 14.7 4.6 - 9.9
As seen in the table above, TSI & TBI assay precision is demonstrated by low averages and narrowness of the total error ranges derived from between-run and within-run data.

Endogenous iron levels were accurately measured in pre-dose study samples which enabled baseline-adjustments of both Total Serum Iron and Transferrin-Bound Iron in post-dose study samples. Transferrin-Bound Iron was accurately separated from Ferumoxytol and free iron using a SPE procedure which discriminated TBI from any other iron source present in study samples.

Despite several assay development challenges, our methodologies have enabled us to overcome the technical hurdles related with the determination of Total Serum Iron and Transferrin-Bound Iron in Pharmacokinetics and Bioequivalence studies.

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