Abstract
www.citoxlab.com IntroductIon In the present study we have examined iron biodistribution and hepatic gene expression following administration of two iron sucrose preparations to rats; Iron Sucrose Azad (ISA), a generic iron sucrose product and Venofer®, a reference iron sucrose product. The biodistribution study was undertaken to address the requirement of the recent European Medicines Agency (EMA) Reflection Paper (1) that comparative data from non clinical studies on the kinetics of iron biodistribution in major target organs should be presented in support of claims of essential similarity for injectable iron sucrose preparations. We have also evaluated the potential hepatic toxicity of these preparations using a gene expression approach.
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