Meeting Regulatory Requirements

Algorithme Pharma | January 2013 e-Bulletin
e-Bulletin / January 2013
Meeting Regulatory Requirements:
Iron Sucrose Ligand Binding Assays
The most recent FDA Guidance recommends that concentrations be reported for both Total Iron (TI) and Transferrin-Bound Iron (TBI) in serum, along with their adjusted baselines. To meet these regulatory requirements, Algorithme Pharma offers generic and product-specific GLP bioanalytical methodologies for Iron-based products.
A well-known challenge for measuring iron in pharmacokinetics studies is to be able to differentiate the relevant iron species while ensuring a linear dose/response correlation. Contrary to other methodologies where data is fitted on a polygonal curve, our TI and TBI assays are calculated using a linear and weighted concentration/response relationship over the 50 to 2,500 µg/dL range. Furthermore, our assays meet stringent stability requirements and are not affected by lipemic (0.15%) or hemolysis (0.4%) conditions. In our TBI assay, iron sucrose and free iron are accurately separated from TBI using a modified SPE chromatographic procedure. This procedure effectively discriminates TBI from iron sucrose over the calibration range, which makes our assay accurate, precise, selective and robust for pharmacokinetic assessment.
Iron supplements continue to be widely used to treat iron deficiency anemia in chronic diseases. Despite the complexities of developing accurate methodologies, Algorithme Pharma continues to develop and offer research methods to meet current and future needs.
For more information, please contact us at contact@algopharm.com.
Contact us at 1 (450) 973-6077, 1 (888) 267-7449, or contact@algopharm.com
www.algopharm.com