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Lissome Drug Products Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling DocumentationGuidance for Industry DRAFT GUIDANCE This guidance document is being
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Liposome drug is a type of medication that uses liposomes, which are tiny spherical vesicles with a lipid bilayer, to deliver drugs to specific targets in the body.
Manufacturers, marketers, or distributors of liposome drugs are required to file them with the appropriate regulatory bodies.
To fill out a liposome drug application, detailed information about the drug's composition, intended use, manufacturing process, and potential side effects must be provided.
The purpose of liposome drugs is to improve the delivery of medications by protecting them from degradation and targeting specific tissues or cells.
Information such as the drug's formulation, intended use, manufacturing process, potential side effects, and safety data must be reported on liposome drug filings.
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