Table of Contents
Liposome Drug Products: Chemistry Manufacturing and Control Issues
Introduction
PPT Slide
Reasons for Making LDPs
Unique Physicochemical and Biopharmaceutical Characteristics
Influence of Lipids on Membrane Properties
Membrane Properties: Lipid Composition
Issue for Concern
Classification of Liposomes
Classification of Liposomes: Size and Lamellarity
Classification of Liposomes: MPS Uptake and Coating
Active Moiety
Demonstration of Sameness after Manufacturing Changes
Uniqueness of LDPs Characterization
Uniqueness of LDPs: Characteristics
How can Changes in Manufacturing be Assessed?
Factors Affecting Sameness
Factors Affecting Sameness: Raw Materials and Their Specifications
Factors Affecting Sameness: Manufacturing Process and Controls
Factors Affecting Sameness: Storage and Reconstitution
Release of Drug
Stability/Compatibility with infusion Fluids and Plasma
Approved Liposome Drug Products
CMC Issues for Liposome Drug Products
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