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
Current effective version
Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2
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.
English (EN) (170.25 KB - PDF)
Document history - Revision 2 (current version)
Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2
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.
English (EN) (170.25 KB - PDF)
Overview of comments received on reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product
English (EN) (420.56 KB - PDF)
Draft reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product
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.
English (EN) (120.19 KB - PDF)
Related content
- Clinical efficacy and safety: clinical pharmacology and pharmacokinetics
- Multidisciplinary: nanomedicines
- Directive 2001/83/EC
- Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party
- Points to consider on switching between superiority and non-inferiority
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Investigation of bioequivalence
- Process validation for finished products – information and data to be provided in regulatory submissions
- Similar biological medicinal products
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues