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

Current effective version

Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2

AdoptedReference Number: EMA/CHMP/806058/2009/Rev. 2Summary:

Development of drug delivery systems to improve disease-specific targeting, to control drug release rates and/or to produce a pharmaceutical formulation suitable for clinical use is desirable.

Document history - Revision 2 (current)

Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2

AdoptedReference Number: EMA/CHMP/806058/2009/Rev. 2Summary:

Development of drug delivery systems to improve disease-specific targeting, to control drug release rates and/or to produce a pharmaceutical formulation suitable for clinical use is desirable.

Draft reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

Draft: consultation closedConsultation dates: 21/07/2011 to 31/01/2012Reference Number: EMA/CHMP/806058/2009Summary:

There has been a significant interest to develop drug delivery methods for potent albeit sometimes toxic, highly lipophilic/poorly water soluble, unstable compounds, or for tissue targeting of highly water soluble compounds. One of the strategies has been encapsulation of the active substance(s) in the aqueous phase of a liposome, or incorporation or binding to the lipid components. Liposomes are classically described as vesicles composed of one or more concentric lipidic bi-layers.