Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Scientific guideline

This document assists in the generation of relevant quality, non-clinical and clinical data to support a marketing authorisation of intravenous liposomal products developed with reference to an innovator liposomal product.

Keywords: Intravenous liposomes, comparability, pharmaceutical quality, pharmacokinetics, non-clinical, clinical studies, liposomal products, generics