Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product - Scientific guideline

This document assists in the generation of relevant quality, non-clinical and pharmacokinetic clinical comparative data to support a marketing authorisation for an intravenous iron-based nano-colloidal product developed with reference to an innovator product.

Keywords: Nano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution

Document history - First version (current)


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